Simtra BioPharma Solutions

• Manage the supplier change notification lifecycle, including evaluation, risk assessment, approval, tracking, and closure. • Perform trend analysis of supplier quality data and proactively identify emerging risks. • Review, analyze, and report supplier trends, including effectiveness and sustainability of corrective actions. • Interface and collaborate with Supply Chain, Incoming Quality, Quality Assurance, Technical Services, Manufacturing, and other stakeholders to resolve supplier quality issues. • Identify, document, and close gaps between Supplier Quality practices and corporate and local procedures, ensuring regulatory and procedural compliance. • Guide and mentor peers in the application of statistically based quality engineering methodologies, including data analysis, interpretation of results, and risk-based decision making. • Assess existing supplier quality processes and recommend improvements to enhance compliance, efficiency, and robustness. • Support supplier qualification, performance monitoring, and ongoing quality development activities, including on-site and remote engagements. • Participate in supplier audits, quality reviews, and business reviews as required. • Ensure supplier quality activities comply with cGMP, global pharmacopoeias, and international regulatory expectations. • Prepare and maintain clear, concise, and compliant documentation, metrics, and reports for internal and external stakeholders.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. The Quality Systems Lead is responsible for managing electronic Quality Management System on a Global level. The Quality Systems Lead is a member of the Global team providing leadership, oversight and decision making to meet deliverables and ensure compliance to applicable policies, procedures, and regulations for projects of responsibility. The Quality Systems Lead must communicate effectively with internal team members, corporate team members, multiple levels of management, and external clients. The responsibilities: - Provide project management leadership for Veeva QMS Workstreams (Quality Docs, Vault Training, QMS, Validation, etc) - Responsible for creating reports, monitoring and maintaining system compliance, creating and owning governing procedures, managing new release activities, supporting validation and configuration activities - Responsible for providing guidance and support for site requests and issue resolution. - Support site regulatory inspection requests. - Serve as Business Administrator for Veeva eQMS - Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams - Work with IT departments for integrations when data is shared cross-functionally - Ensure compliance with all applicable policies, procedures, and regulatory requirements - Ensure the appropriate level of harmonization between sites to efficiently meet customer and regulatory expectations. - Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations. - Regularly interact with senior management or executive levels on key quality projects - Interface with the staff/customers to ensure Simtra quality commitments are met. - Facilitate an environment of teamwork and communication between cross-functional departments and sites to meet Company goals/objectives. Desired qualifications: - Bachelor's degree in Life Sciences, Engineering, or related field - 7 years experience in Quality / equivalent pharmaceutical industry experience - Served in a role providing project management disciplines with proven experience for implementation and maintenance of electronic Quality Management software, PMP preferred. - Experience with Veeva software, Quality Docs, Vault Training, QMS, Controlled Print - Knowledge of GxP / CSV regulations - Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams - Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization - Strong analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner - Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement - Computer proficiency in Microsoft Word, Excel, Outlook, Visio, Project etc. At Simtra, we recognize that attracting the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure we are able to attract the best candidates.​ The pay range reflected represents what we reasonably expect to pay for this job. The pay offered will depend on factors such as the candidate’s education, experience, skills, and geographical location. In addition to base pay, employees are eligible to participate in an annual bonus plan and employee ownership plan. Eligible employees also receive a comprehensive and highly competitive benefits package, including a variety of health, retirement, caregiving, emotional wellbeing, and other flexible benefits—plus elective options to support the diverse needs of our workforce.​ Salary Range: $104,000-$143,000 In return, you’ll be eligible for[1]: - Day One Benefits - Medical & Dental Coverage - Flexible Spending Accounts - Life and AD&D Insurance - Supplemental Life Insurance - Spouse Life Insurance - Child Life Insurance - 401(k) Retirement Savings Plan with Company Match - Time Off Program - Paid Holidays - Paid Time Off - Paid Parental Leave and more - Adoption Reimbursement Program - Education Assistance Program - Employee Assistance Program - Community and Volunteer Service Program - Employee Ownership Plan - Additional Benefits - Short and Long-Term Disability Insurance - Voluntary Insurance Benefits - Vision Coverage - Accident - Critical Illness - Hospital Indemnity Insurance - Identity Theft Protection - Legal and more - Onsite Campus Amenities - Workout Facility - Cafeteria - Credit Union [1] Current benefit offerings are in effect through 12/31/26 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

• Support and advise our business units in the development and implementation of recruiting strategies • Independently manage the entire recruitment process for specific departments at the site • Select relevant recruiting channels and actively identify and approach qualified candidates using social media • Prepare, conduct and follow up on competency-based interviews • Provide individual guidance and support to candidates throughout the recruitment process to ensure a consistently positive candidate experience • Coordinate and conduct contract negotiations, including preparing offers and contracts in collaboration with the HR department • Continuously expand and maintain networks in the candidate market and participate in recruiting events

Join The Simtra Talent Community Are you passionate about making an impact in the Contract Development and Manufacturing Organization (CDMO) industry? Even if you don’t see a current role that matches your skills and interests, we’d love to stay connected with you! By joining our Talent Community , you'll be the first to know about exciting new opportunities across a wide range of roles within the CDMO industry, including areas like: Research and Development : Contribute to innovative solutions that drive progress. Manufacturing and Operations : Ensure high-quality production and efficiency. Quality Assurance and Regulatory Affairs : Maintain excellence and compliance. Project Management : Lead transformative projects from concept to completion. Business Development : Drive growth and foster meaningful partnerships. As a valued member of our Talent Community, you'll receive: Early notifications of new job openings in the CDMO sector. Updates on company news and advancements. Exclusive insights into what it’s like to work with us. We’re always looking for talented individuals who are eager to make a difference. Take the first step— join our Talent Community today —and let’s shape the future of the CDMO industry together!