Sr Associate III, Quality Assurance Inspection Management
Location: Research Triangle Park, NC
Remote Type: On Campus
Time Type: Full time
Job Description
About This Role:
As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility. Your expertise in GMP activities ensures that our quality systems remain compliant with industry standards. You will lead the charge in managing site inspections, regulatory requests, and overseeing the creation and approval of GMP documents. Your ability to balance departmental workload, mentor team members, and manage key projects will significantly contribute to our team's success. This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment to quality and excellence.
What You’ll Do:
Manage regulatory and partner inspections, ensuring timely inspection setup, support, and closure
Lead inspection readiness activities, including planning and execution
Process regulatory requests to support submissions and approvals across various markets
Provide quality oversight on regulatory responses and ensure timely closure of audit responses
Identify and implement improvements within the Quality System.
Develop and deliver training on GxP quality systems, offering mentorship within and across functions
Manage key functional projects and support other QA functions as needed
Other duties as assigned
Who You Are:
You have a keen eye for detail and a proactive approach to quality management. Your strong organizational skills enable you to juggle multiple projects while maintaining precision and adherence to timelines. You thrive in collaborative settings, providing mentorship and training to foster growth. Your deep understanding of quality systems and regulatory requirements allows you to make autonomous decisions confidently. You are a natural leader, capable of driving initiatives and improvements that align with our business goals.
Required Skills:
Minimum Bachelor’s degree in a scientific/technical discipline
Minimum 7 years of experience working a pharma, biotech or medical device regulated/GMP industry (or Associate's Degree with 9+ years related experience)
Demonstrated leadership abilities and can lead complex problem-solving initiatives across functions or globally
Knowledge of FDA/EMEA regulations, Annex 1, ICH, etc
Ability to communicate, present, and facilitate meetings with senior management and senior leadership (SLT)
Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel
Proficient understanding of quality systems
Demonstrated troubleshooting and problem-solving skills
Strong oral and written communication skills
Preferred Skills:
Highly desired experience being a back room coordinator during audits and/or hosting in the front room
Experience with partner audits
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 $10,000 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 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 E-Verify Employer in the United States.
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