Associate Director, Quality Assurance & Governance - R&D Quality & Compliance

Job Description

About This Role

The Associate Director, Quality Assurance & Governance - R&D Quality & Compliance (RDQC) will provide strategic guidance, oversight and support for the quality activities within the Quality Management System (QMS), including regulatory health inspections and the overall R&D audit management. Partners with other quality and compliance groups across R&D and PO&T functions to enable transparency, escalation and risk minimization of quality and compliance issues. Provides oversight and trending of relevant quality metrics; proactively assessing potential quality risks and recommends mitigating / remediating actions to key stakeholders and quality governance.

What You’ll Do

• Serve as an accountable party for ensuring quality oversight of regulatory inspections by assisting in developing an inspection management framework, engaging in inspection readiness activities with clinical study teams and staging of key documentation for inspector review.
• Responsible for driving resolution to regulatory health authority inspection findings and reporting in a timely manner to the relevant party.
• Leads the development and maintenance of the R&D Audit infrastructure, including audit risk assessment and contribution to the Annual Audit Plan.
• Provides oversight of end-to-end audit conduct by audit functional service providers or directly auditing stakeholders using applicable knowledge of GxP’s.
• Oversees the operational process refinement efforts and potential execution of other quality management processes, including, risk management, and process improvement.
• Responsible for overseeing relevant quality metrics; proactively assessing potential quality risks and recommends mitigating actions to drive quality metrics, in line with predetermined expectations.

Who You Are

You have a demonstratable knowledge of GxP regulations and ability to implement these requirements in processes, procedures and systems. You are interested in building your quality expertise, with a key focus on audit management and regulatory inspections. You are adaptable and able to manage competing priorities, with key strengths in communication and problem solving.

Qualifications

Required Skills

• Bachelor’s degree required.
• 8 years’ Clinical Trial experience working in the biotechnology or pharmaceutical industry required; work with CROs highly desirable.
• 6 years’ experience in a quality role required.
• Experience with regulatory inspections and audits required.
• Experience with Quality Management Systems required.
• Extensive knowledge of the principles GxP regulations, including, GCP, GVP and preferably GLP, required.
• Experience in process development and process improvement required.
• High attention to detail, including proven ability to manage multiple, competing priorities, and strong problem-solving and communication skills, required.
• Ability to Influence the opinions and decision making of others internally or with external partners/vendor/customers required.

Preferred Skills

• Masters’ degree or PhD in Biology / Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred.
• Work with CROs preferred.

Additional Information

The base salary range for this position is $163,000 - $225,000. Base salary offered is determined though an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:

• 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 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 Res