Job Closed

This listing is no longer active.

BioScript Solutions logo
BioScript Solutions

At BioScript, everything we do starts with a single question: "What’s best for the patient?" | Est. 2001 | bioscript.ca

Associate Manager, Quality Assurance – Governance

QA EngineerQA EngineerFull TimeRemoteMid LevelTeam 1,001-5,000Since 2001H1B No SponsorCompany SiteLinkedIn

Location

Canada

Posted

51 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree10 yrs expEnglish

Job Description

Associate Manager, Quality Assurance – Governance

BioScript Solutions

• Audit Governance (Internal, External & Client Audits) • Develop and maintain governance dashboards and KPI packages for audits, CAPA, deviations, suppliers, and commitments. • Own the Quality Audit Program including risk‑based planning, execution, reporting, and post‑audit governance activities. • Lead all internal audits, ensuring audit scopes, tools, documentation, and reports meet QMS and regulatory requirements. • Act as the primary QA lead during external and client audits, managing readiness, evidence compilation, SME coordination, and audit execution. • Document audit observations with objective, risk‑aligned language and ensure timely, high‑quality responses. • Govern the closure of audit‑related action plans and CAPAs, verifying effectiveness, sustainability, and escalation of risks. • Maintain audit governance documentation, schedules, templates, and systemic trend analyses. • Oversee CAPA and action‑plan governance ensuring problem statements, RCAs, risk scoring, and actions meet quality standards. • Review CAPA packages for clarity, completeness, effectiveness, and sustainability. • Track CAPA timeliness, effectiveness checks, recurrence trends, and escalate systemic issues. • Lead supplier qualification and re‑qualification including risk tiering, documentation review, and assessments. • Govern supplier performance monitoring, issue escalation, and remediation planning. • Collaborate closely with Procurement, Operations, Clinical, and Pharmacy teams to manage supplier risks. • Develop, review, negotiate, and maintain Quality Agreements with clients and suppliers. • Track contractual quality commitments, deliverables, and evidence required for audits. • Provide guidance to teams regarding Quality Agreement interpretation and obligations. • Analyze trends to identify risks and systemic improvement opportunities. • Present concise governance insights to leadership, clients, and cross‑functional teams. • Ensure data accuracy, traceability, and integrity in governance systems. • Serve as a key QA Governance contact for clients, suppliers, and internal partners. • Support client governance meetings with reporting, metrics, audit updates, and quality insights. • Lead communications on externally reportable issues and risks to service continuity. • Lead and coach the QA Governance team, managing workload, performance, and skill development. • Provides clear direction, sets measurable goals, and holds team members accountable for performance and results. • Coaches, develops, and supports team members through regular feedback, performance reviews, and career development planning. • Fosters a high-performing, inclusive team culture that aligns with company values and business objectives. Act as back‑up for the Manager, QA Governance for escalations, governance decisions, and external interactions.

Job Requirements

  • Education: Bachelor’s degree in life sciences, pharmacy, nursing, health administration, quality, or a related discipline (or equivalent combination of education and experience).
  • Experience: 7–10 years of progressive QA experience in regulated healthcare, pharmaceutical, clinical, PSP, or GxP environments.
  • Experience owning internal audit programs and leading client/external audit activities.
  • Experience in CAPA governance, supplier quality oversight, and Quality Agreement administration.
  • Skills: Strong knowledge of QMS elements, root cause analysis, and risk-based decision-making.
  • Preferred Certifications: ASQ CQA, CQE, CSQP, Lean Six Sigma Green Belt or higher.
  • English proficiency is required for this position to effectively communicate with internal and external stakeholders. Bilingualism (French and English) may be required depending on the specific role, location, and the needs of the organization.

Benefits

  • Epic Work-Life Balance: Flexible remote work options because we value your time and well-being.
  • Growth Opportunities: Committed to fostering a culture of growth, where every team, member is encouraged to pursue new skills, expand their knowledge, and advance their careers.
  • Vibrant Culture: Over 1,500 team members across Canada and year over year we manage to maintain an overall above industry engagement score by using a monthly pulse survey.
  • Attractive Compensation: Competitive salary, incentive program, and comprehensive benefits package.

Related Categories

Related Job Pages

More QA Engineer Jobs

Principal Software Quality Assurance Engineer

Solventum

Solventum is dedicated to improving healthcare options and health outcomes through cutting-edge solutions in health, materials, and data science. The company ai

QA Engineer51 days ago

• Leading software assurance activities throughout medical device software life cycle • Creating software quality assurance plan • Determining software safety classification • Software test readiness and software release readiness • Ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing • Being an active member of the software team during the whole software life cycle • Responsibility for physical and functional configuration audits • Reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results • Providing insight to management regarding software project status and software quality metrics • Ensuring compliance with applicable regulatory requirements and industry standards • Performing gap assessments • Immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements • Acting as a quality champion in software product development and testing teams • Supporting other software related processes such as CAPA process and other quality related processes regarding cybersecurity risk management and software quality assurance.

Minnesota + 1 moreAll locations: Minnesota | Texas
$124K - $170.5K / year

Automated Tester

Alpha Omega Integration

Alpha Omega Integration is a mission-driven IT solutions provider dedicated to ensuring the United States’ continued global leadership through innovative and

QA Engineer51 days ago

• Lead quality assurance activities portfolio wide • Establishing and executing a comprehensive test strategy • Performing functional, regression, and integration testing • Managing defect tracking and enforce quality gates prior to release • Standardizing Documentation • Supporting audit and compliance requirements • Reducing production defects and incident volumes • Supporting Future Modernization Initiatives

Virginia
$91K - $130K / year
Job Closed
Full TimeRemoteTeam 11-50Since 2018H1B No Sponsor

• Test SEPA credit transfer flows, SWIFT MT / ISO 20022 message flows, and Visa card payment flows including 3DS2 authentication. • Perform API , contract, schema, and integration testing at the microservice layer, including async / event-driven workflow testing across queues, retries, and DLQ. • Execute structured test scenarios across SEPA , SWIFT , and Visa payment workstreams and validate end-to-end transaction lifecycle flows, reconciliation, settlement, and data consistency. • Conduct resilience testing including retries , circuit breakers , DLQ , failover, and idempotency validation, as well as performance, load, and stress testing for platform stability. • Develop, execute, and integrate automated test suites into CI/CD pipelines. • Produce audit-grade test evidence and traceability documentation for PCI DSS compliance. • Validate web, mobile, and cross-platform functional consistency and regression coverage. • Collaborate with developers, DevOps , and security teams to identify, track, and verify defect resolution.

Lithuania
Job Closed
SixGen, Inc. logo

Red Team Operator I

SixGen, Inc.

SIXGEN’s mission is to deliver agile, mission-ready cybersecurity solutions that empower government and critical infrastructure organizations to stay ahead of advanced cyber threats. We combine innovation, deep expertise, and cutting-edge capabilities to uncover vulnerabilities, protect vital systems, and ensure operational superiority in an ever-evolving digital landscape.

QA Engineer51 days ago
Full TimeRemoteTeam 51-200

Role Description SIXGEN supports cyber and intelligence missions by serving government and commercial organizations as they overcome global cybersecurity challenges. You’ll work with our highly skilled operators conducting research and assessments based on real-world threats. You’ll simulate adversaries and malicious actors and report details and actionable findings on critical assets and infrastructures. Using innovative processes, tools, and techniques, you’ll predict and overcome cybersecurity vulnerabilities. What You’ll Do - Simulate real-world cyberattacks to assess and challenge the effectiveness of security controls and incident response capabilities. - Conduct reconnaissance, exploitation, and post-exploitation activities using adversary tactics, techniques, and procedures (TTPs). - Develop and use custom tools and methods to evade detection and maintain stealth during engagements. - Document findings and deliver clear, actionable reports to technical and executive stakeholders. Qualifications - Experience performing OSINT/reconnaissance, enumeration, web application testing, social engineering, payload development, initial access, system enumeration, lateral movement, privilege escalation, data exfiltration. - Participates in report writing process and can professionally convey findings and impact to customers, both written and verbally. - Practical offensive certification: CRTO, OSCP, CPTS, or similar. - At least 2 years of independently executing complete red team engagements, from planning through post-exploitation. - At least 2 years modifying/red-teaming tools (e.g., Cobalt Strike, Kali) and 2+ years developing payloads to bypass A/V and EDR defenses. - Experience performing engagements on cloud, hybrid, multi- and/or single-tenant active directory environments such as AWS, GCP, Entra. - In-depth knowledge and experience with Windows and *NIX-based operating systems, networking concepts, and Active Directory. Requirements - Clearance Requirements: None, but Public Trust preferred. - Travel: Up to 10%. Benefits - Employer-paid health insurance premiums (medical, dental, vision) for you and your family. - Employer-paid short/long term disability insurance and basic life/AD&D insurance. - 401K with a 4% employer contribution. - Professional development reimbursement options available (training, certification, education, etc). - Flexible and remote work policies for most positions. - Flexible PTO and holiday schedule. Company Description SIXGEN’s mission is to deliver agile, mission-ready cybersecurity solutions that empower government and critical infrastructure organizations to stay ahead of advanced cyber threats. We combine innovation, deep expertise, and cutting-edge capabilities to uncover vulnerabilities, protect vital systems, and ensure operational superiority in an ever-evolving digital landscape.

United States
$100K - $150K / year
Job Closed