Sr. Associate II, Compliance

Biogen•Research Triangle Park, NC

1d•$93,000 - $121,000•Onsite

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. 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.

Requirements

Bachelor’s 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

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 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

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