Sr. Associate II, Compliance

Biogen • Research Triangle Park, NC

6d

About The Position

The Sr. Associate II, Compliance plays a critical leadership role in ensuring the RTP Drug Substance Manufacturing site maintains a strong state of compliance and inspection readiness. The position partners with Site Leadership and Quality teams to oversee inspection management, data integrity, and quality systems, while driving continuous improvement across local and global processes. The role helps ensure adherence to regulatory requirements and strengthens a culture of quality and compliance across the organization.

The position leads site compliance and inspection activities, provides oversight across data integrity, risk management, and quality systems, and supports quality governance and data-driven decision-making. It also represents Quality on cross-functional teams and site leadership initiatives.

Requirements

• Bachelor’s degree in a scientific, technical, or relevant discipline; additional years of experience may be considered in lieu of a degree.
• At least 5 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments.
• Strong knowledge of cGMP regulations and global regulatory standards, including FDA and EMA requirements.
• Experience with inspection management, compliance oversight, and quality systems.
• Demonstrated ability to analyze data, manage risk, and support regulatory interactions.
• Excellent communication, organizational, and problem-solving skills.
• Ability to manage multiple priorities and make decisions under pressure.

Nice To Haves

• Prior experience in Compliance-focused Quality roles.
• Experience with quality systems such as Veeva, TrackWise, and Power BI.
• Strong knowledge of data integrity principles and regulatory expectations.
• Experience supporting global quality initiatives and cross-functional teams.
• Proven ability to drive continuous improvement and influence stakeholders.

Responsibilities

• Lead site compliance and inspection management activities, including planning, execution, and regulatory response coordination.
• Ensure the site remains inspection-ready for domestic and international regulatory agencies.
• Provide compliance oversight across data integrity, risk management, and quality systems.
• Prepare and facilitate site governance meetings and deliver quality metrics using tools such as Veeva, TrackWise, and Power BI.
• Drive quality management review processes and lead quality metric governance to support data-driven decision-making.
• Partner with global quality forums to ensure alignment with the global Quality Management System (QMS).
• Lead and support process and product risk assessments, ensuring timely completion and effectiveness.
• Identify and proactively resolve compliance gaps and technical issues.
• Champion continuous improvement initiatives across quality systems and processes.
• Serve as a key Quality representative on cross-functional teams and site leadership initiatives.

Benefits

• Medical, dental, vision, and life insurance.
• Fitness and wellness programs, including fitness reimbursement.
• Short- and long-term disability insurance.
• A minimum of 15 days of paid vacation and additional end-of-year shutdown time off from December 26 through December 31.
• Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
• 80 hours of sick time per calendar year.
• Paid maternity and parental leave.
• 401(k) program with company-matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Employee Resource Groups participation.
• Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level