Sr Manager, Quality Assurance & Governance

Biogen • Cambridge, MA

103d • $131,000 - $175,000 • Hybrid

About The Position

The Senior Manager role within Quality Assurance & Governance (QAG) serves as a Research and Development Quality and Compliance (RDQC) representative providing expert auditing, inspection support and quality governance support to Biogen Research, Development and Medical (RD&M) stakeholders. The position directly supports the RD&M GxP Audit Program by contributing to planning, conduct, approval and close-out of audits, and supporting GxP/GVP audit strategy, risk assessment and annual audit planning using a risk-based approach for selection of internal and external audits. Additionally, they will have responsibility for implementing a culture of quality and compliance across RD&M, contributing to cross-functional quality improvement initiatives and support of inspections.

Requirements

• Bachelor's Degree required in scientific field.
• 5+ years' experience in pharmaceutical/biotechnology industry with 5+ years of GVP, GCP, GLP/GCLP operations and/or quality and compliance experience.
• Direct experience with Good Practice (GxP) guidelines, compliance quality systems, and PV knowledge is preferred.
• Experience in any of the following areas: audits, inspection management, inspection readiness, CAPA management, quality risk management or related quality management system responsibilities.
• Working knowledge and understanding of the GxP regulations including USA (FDA), EU (EMA and MHRA), Japan (PMDA), ICH Guidelines and general compliance.
• Detail oriented and quality mindset; ability to work in a team environment and set priorities appropriately.
• Strong understanding of GVP, GCP, GCLP/GLP and/or audit processes in the biotech, pharmaceutical, and/or CRO industry.
• Strong time management, project management, organizational, communication and interpersonal skills.
• Strong computer/technical skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and MS Outlook.
• Audit database and database query experience, desired.
• Excellent written and verbal communication skills, including strong ability to facilitate meetings/discussions, and ability to collaboratively partner with cross-functional area colleagues.
• Experience leading or executing some or all quality activities including but not limited to audit, inspection, controlled documentation, deviations, quality issues, training, vendor management, and quality risk management.
• Ability to identify areas for process improvement and lead discussions to implement change.

Responsibilities

• Provides input into the GxP/GVP annual audit strategy, risk assessment and annual audit plan.
• Facilitate the planning, conduct, approval, and close-out of audits performed by qualified auditors.
• Collaborate with internal and external stakeholders to obtain key audit information and documents in support of audit planning and researching the audit area to develop appropriate audit scope.
• Facilitate pre-audit and audit debrief meetings with key stakeholders.
• Oversee the execution of the end-to-end audit processes to ensure the coordination and execution of audit scope and follow-up activities with relevant stakeholders.
• Lead and participate in audit process improvement initiatives.
• Develop and perform quality review of documentation in support of audit management.
• Participate in functional and cross-functional quality process improvement initiatives.
• Support investigations, root cause analysis and implementation of actions for relevant quality issues, CAPAs or Effectiveness Checks.
• Support inspection readiness, preparation and execution activities.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree