Sr Associate III Quality Assurance Inspection Readiness

This is a full time onsite position

About This Role  

This position will support our drug substance (Bio) site at our Research Triangle Park NC facility. The primary responsibilities of the Senior Associate III include quality compliance for managing site inspections completing regulatory requests for partner and Biogen products authoring Site Reports (Site Management Review Report and Site Master File) change control support and the review and approval of sitespecific GMP documents (Work Instructions Master Production Records and Solution Records) for compliance to applicable regulatory and corporate guidance documents and consistency with business source documentation.

What Youll Do  

• Management of regulatory and partner inspections and regulatory requests for the RTP DS (Bio) site through inspection set up inspection team support response management closure of inspection workflows and identifying overall inspection trends.
• Lead site inspection activities through planning and readiness related to inspection schedule and response activities.
• Process and complete regulatory requests in a timely manner to support regulatory submissions and approval status across several markets.
• Serve as quality oversight on regulatory responses in the quality system. Provide quality oversight of adequate documentation and on time closure of audit responses to any inspection findings.
• Identify and implement Quality System improvements.
• Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions.
• Other duties as assigned.

Qualifications :

• Bachelors degree required science related field preferred
• Minimum 7 years of industry experience in a GMP/cGMP environment within pharmaceutical or biotech manufacturing 
• Expert knowledge of FDA/EMEA regulations and compliance
• Expertise in managing and conducting audits
• Demonstrated leadership abilities and can lead complex problemsolving initiatives across functions or globally (Coordinates activities across these groups to complete compliance activities)
• Project management experience including strong organizational skills and ability to multitask and coordinate multiple activities in parallel
• Strong oral and written communication skills; ability to communicate with peers and subordinates effectively

Additional Information :

The base salary range for this position is $annually. 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 longterm 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 wellbeing; including but not limited to:

• Medical Dental Vision & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short and LongTerm Disability insurance
• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 on to learn more about our DE&I efforts.

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 EVerify Employer in the United States.