Sr. Associate II, Compliance

About This Role

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. This position partners closely with Site Leadership and Quality teams to oversee inspection management data integrity and quality systems while driving continuous improvement across local and global processes. This role is instrumental in ensuring adherence to regulatory requirements and strengthening a culture of quality and compliance across the organization.

What Youll Do

• Lead site compliance and inspection management activities including planning execution and regulatory response coordination
• Ensure the site remains inspection-ready at all times 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

Who You Are

You are a proactive and detail-oriented quality professional with a strong foundation in compliance and regulatory expectations. You bring a continuous improvement mindset and thrive in fast-paced highly regulated environments where collaboration and data-driven decisions are essential.

Required Skills

• Bachelors degree in scientific technical or relevant discipline
• At minimum 5 years of Quality Assurance experience in pharmaceutical biotech or manufacturing environments
• Strong knowledge of cGMP regulations and global regulatory standards (FDA EMA etc.)
• 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

Preferred Skills

• 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

Additional Information

Base salary offered is determined through 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 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 $10000 per calendar year
• Employee Resource Groups participation

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.