Title: Head of Quality North America Location: Raleigh United States Employees work in a hybrid mode Full-time Sobi Location: United States Job Description: Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: - Competitive compensation for your work - Generous time off policy - Opportunity to broaden your horizons by attending popular conferences - Emphasis on work/life balance - Collaborative and team-oriented environment - Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Job Description At Sobi, quality is not a function - it's a promise to patients. As Head of Quality North America, you will play a pivotal role in ensuring that promise is delivered every single day. This is a senior, high‑impact leadership role where your expertise, judgment, and ability to inspire others will directly influence patient safety, regulatory trust, and business success across the region. You will be the most senior Quality leader in North America, a trusted partner to global leadership, and the primary Quality voice with FDA and other health authorities - all while building a strong, engaged Quality organization that is proud of the standards it sets. The position is Hybrid, based in our office in North Carolina, Raleigh, reporting to Chief Quality Officer. Your impact will include: In this role, you will: - Set the quality vision and governance for North America, ensuring alignment with global strategy and regulatory expectations - Act as the senior Quality interface with FDA, Health Canada, and regional authorities, leading inspections with confidence and credibility - Drive inspection readiness and compliance excellence across all GxP areas (GMP, GDP, GCP, GVP) - Ensure robust product quality and supply continuity, from batch disposition to market release - Provide strategic oversight of external manufacturing partners, suppliers, and logistics providers - Lead continuous improvement initiatives that strengthen quality culture, data integrity, and right‑first‑time execution - Build, develop, and inspire high‑performing Quality teams across North America Qualifications About you You are a seasoned Quality leader who combines deep regulatory expertise with strong business acumen and genuine people leadership. You're comfortable operating at executive level, yet equally committed to coaching leaders and teams to grow, thrive, and take ownership. You bring calm and clarity to complex situations, make sound risk‑based decisions, and lead with integrity - especially when it matters most, such as during inspections or critical quality events. You enjoy working in global, matrix organizations and know how to balance regional accountability with global alignment. Above all, you are motivated by purpose. You care deeply about patient safety, believe in building a strong Quality culture, and want your work to make a meaningful difference. Key talents and experience - Master's degree (or higher) in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or similar - 15+ years' experience in pharmaceutical or biotech Quality roles - 5+ years of people leadership with a proven ability to build and develop strong teams - Extensive GMP experience, with solid working knowledge of GDP, GCP, and GVP - Proven leadership during FDA inspections and direct interaction with health authorities - Strong experience overseeing external manufacturers and partners in a global matrix environment - Ability to influence senior stakeholders and navigate complex, cross‑functional organizations Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership! Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: - A competitive 401(k) match to support your financial future. - Tuition and wellness reimbursements to invest in your personal and professional growth. - A comprehensive medical, dental, and vision package to prioritize your health and well-being. - Additional recognition awards to celebrate your achievements. The base salary range for this role is $220,000 - $300,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Type of Requisition: Regular Clearance Level Must Currently Possess: Secret Clearance Level Must Be Able to Obtain: Secret Public Trust/Other Required: None Job Family: Program Delivery and Execution Job Qualifications: Skills: Project Requirements, Quality Assurance (QA), Quality StandardsCertifications: NoneExperience: 5 + years of related experienceUS Citizenship Required: Yes Job Description: SITE QUALITY LEAD (Quality & Standards Oversight) Overview The Site Quality Lead is responsible for ensuring the accuracy, completeness, and compliance of all engineering deliverables produced by the site team—including Network, OSP, FO, CEL, ISP, and DS Lead workstreams—across global Air Force and Space Force installations. This role oversees quality assurance processes, validates engineering outputs, ensures adherence to AF/SF, UFC, I3A, NEC, and TIA/EIA standards, and manages Agency and Subcontractor performance related to quality control. The Site Quality Lead acts as the final technical gatekeeper prior to submission of deliverables to the Government. Primary Responsibilities • Oversee quality assurance for all engineering deliverables generated at each site, including network, OSP, FO, and CEL surveys, drawings, redlines, reports, as-builts, and technical documentation • Verify compliance with required standards including TIA/EIA, UFC, I3A, NEC, and AF/SF engineering and construction criteria • Manage quality oversight of GDIT, Agency, and Subcontractor labor, ensuring all inspections, installations, and documentation meet project standards • Develop and enforce standardized QA/QC processes, workflows, and checklists for all DS workstreams • Conduct on-site inspections, verification walks, and technical audits to ensure the accuracy of engineering data and field results • Coordinate with DS Lead, OSP, FO, and CEL engineers to resolve discrepancies, design conflicts, deficiencies, or quality issues • Track quality-related risks, document non-conformance items (NCIs), and ensure remediation is completed • Facilitate internal quality review meetings and collaborate with PMs and technical leads on corrective actions • Review and validate as-built packages for completeness, accuracy, and alignment with installed conditions • Support customer briefings and technical discussions as the quality subject matter expert • Maintain deep knowledge of DoD, AF/SF, and TIA/EIA standards to ensure all deliverables meet or exceed required quality levels Required Experience 7–10 years in telecommunications engineering, infrastructure installation, or DoD network modernization • Demonstrated experience in quality assurance or quality control within telecom, OSP/ISP, or similar engineering projects • Strong familiarity with TIA/EIA standards (TIA-568, TIA-569, TIA-606, TIA-607, TIA-598, and fiber testing standards) • Experience reviewing OSP, fiber, telecom room, and structured cabling designs for compliance and accuracy • Prior experience managing subcontractor quality or installation oversight • Experience supporting AF/SF or federal modernization programs strongly preferred • Knowledge of OSP construction, fiber testing, and telecom room environmental/grounding requirements Preferred Experience • Experience with AFNET, DISA, or large federal telecommunications programs • Experience with quality management systems (QMS), inspections, and non-conformance tracking • Experience generating or reviewing telecom engineering drawings and as-built documentation Certifications (Preferred or Required) • BICSI RCDD (strongly preferred) • BICSI OSP, Installer 2, or Technician certifications • FOA CFOT (preferred for fiber QA roles) • PMP, CAPM, or equivalent quality/project management certifications beneficial • OSHA 30 or similar safety certification (for site inspection work) • CCNA (preferred) #BIM The likely salary range for this position is $96,569 - $130,651. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: 10-25% Telecommuting Options: Remote Work Location: Any Location / Remote Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. GDIT typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year. Paid leave and paid holidays are prorated based on the employee’s date of hire. The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology. Join our Talent Community to stay up to date on our career opportunities and events atgdit.com/tc. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

Klara Team är arbetsplatsen för dig som är trygg i din roll att arbeta fritt och självständigt med att utföra medicinska bedömningar med stöd av kollegor och våra jourläkarorganisationer. Klara Team har arbetat sedan 2002 med att leverera hållbara sjukvårdslösningar inom SÄBO och LSS. Vår värdegrund genomsyras av ett vänligt bemötande och präglas av våra värdeord: Ansvar, Enkelhet, Kunskap och Respekt. Vad innebär det att vara sjuksköterska hos oss? Arbetspassen är förlagda vardagar 16.00-02.00 följt av beredskap till 08.00. Helger är arbetspassen förlagda 08:00-18:00 eller 18:00-02:00 följt av beredskap till 08:00. Tjänstgöringgraden är individuell men vanligtvis kring 70%. Du utgår hemifrån och ansvarar för hälso- och sjukvård på ett antal vård- och omsorgsboenden i Västerås, Enköping & Eskilstuna. Det finns även ett kontor tillgängligt dygnet runt i Västerås. Du utför planerade och akuta besök samt ger rådgivning per telefon till boendets personal. Vi arbetar med evidensbaserade beslutsstöd. Du är ett stöd för både patienter, närstående och personal. Vi tillhandahåller verksamhetsbil. Vem är du? - Du gillar att arbeta självständigt och att ha friheten att utforma dina arbetsdagar. - Du är trygg i din roll som sjuksköterska efter minst 3 år och kan fatta snabba beslut. - Du tar egna initiativ, vågar ta för dig och kan ha många bollar i luften. - Du tycker om att ha en ledarroll och stöttar dina kollegor. - Du är van att strukturera och organisera ditt arbete. - Du vill göra skillnad för våra äldre och är alltid vänlig i bemötandet. - Du är en bra bilförare. - Du är trygg med att arbeta i olika journalsystem. Körkort och datorvana är ett krav, likaså att du ska kunna uttrycka dig mycket väl på svenska i tal och skrift. Specialistutbildning eller erfarenhet från akutsjukvård, hemsjukvård, palliativ vård och geriatrik är meriterande. Om företaget: Klara T ingår i företagsgruppen Ambea Sweden Group som är ett av Nordens ledande omsorgsföretag. Inom vår företagsgrupp erbjuder vi boende, stöd, utbildning och bemanning inom vård och omsorg. Ambeas verksamhet präglas av etisk medvetenhet och en etikpolicy. Företagspolicyn bygger på fyra nyckelord: kunskap, engagemang, ansvar och respekt. Klara team arbetar varje dag med Ambeas vision, ”Vi gör världen lite bättre, en människa i taget” genom vår ambition att bygga långsiktiga relationer med våra kunder. Vi på Klara Team förser vård- och omsorgsboenden, LSS och servicehus med sjuksköterskepatruller under kvällar, nätter och helger i Stockholmsområdet, Gotland, Uppland, Gävle, Östergötland, Västmanland, Sörmland samt Skåne. Vi går igenom ansökningar löpande, vid frågor är du välkommen att höra av dig. Vi erbjuder dig: Friskvårdsbidrag vid tillsvidareanställning, fortlöpande kompetensutbildning, trygg anställning genom kollektivavtal och försäkringar och härliga arbetskamrater. Vi ser framemot din ansökan! Klara - Ett kompetensföretag inom vård och välfärd. Vi gör världen lite bättre en människa i taget. Om du har frågor, kontakta enhetschef Andreas Holmlund, andreas.holmlund@klarakompetens.se

• Responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines • Participate in day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures • Support the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas • Provide expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies • Include inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors • Lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP) • Support clinical study teams as a core team member for assigned studies through attendance at study management team meetings, review of study documents, and QA consultation on GCP - related questions • Identify and escalate serious non-compliance issues to Clinical QA and Quality group leadership, including the assessment of serious breaches • Maintain a high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct • Collaborate with CRO quality counterparts as delegated, including participation in QA-QA meetings • Participate in internal and external GCP audits as assigned in support of the execution of the audit programs and support the management of audit lifecycle activities as assigned, such as scheduling planning, issuing agendas, audit execution, issuing reports evaluating responses, requesting clarification, issuing CAPA, and audit closing • Maintain up to date audit execution results in Arcus electronic quality management system (Veeva Quality Vault, preferred) and report compliance trends based on internal / external regulatory observations to ensure business continuity • Clearly present audit findings and/or other related audit information to appropriate departmental personnel, as required • Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits • Support Quality Assurance activities during partner audits and/or regulatory inspections, as assigned • Participate in inspection readiness and pre-approval inspection preparation activities and collaborate with study and functional area teams, applicable partners and CROs as assigned • Support strategic organizational quality and compliance process improvement initiatives • Support Investigator Site Audits