Sr. Associate III, Quality Control
About This Role:
As the Sr. Associate III for Quality Control within the Global External Testing Management team, you will play a crucial role in ensuring the timely and compliant release of our products. You will be responsible for overseeing all aspects of testing conducted at contract laboratories, which support both internal and external manufacturing processes. Your strategic leadership will be essential in managing financial planning, contract management, and driving process innovations that balance cost with value, aligning with our Vision 2030 objectives. In this role, you will have the opportunity to influence cross-functional operations, make decisive testing strategy decisions, and effectively communicate risks impacting product release and compliance. This position serves as a vital component in our business structure, contributing to the overall success and efficiency of our quality control operations.
What You'll Do:
- Develop, implement, and manage multiple quality control projects supporting contract laboratory management and product testing.
- Communicate and manage external testing and project status, spending, and direction with stakeholders.
- Identify and implement process improvements to enhance efficiency, compliance, and communication across contract laboratory operations.
- Ensure robust information management and documentation practices to support audit readiness and regulatory compliance.
- Manage financial aspects of external testing, including purchase order creation, spend tracking, and budgeting/budget reforecasting.
- Lead and oversee key site/global projects while providing mentorship to team members.
- Influence and coordinate with cross-functional teams to achieve departmental objectives.
- Escalate risks and compliance gaps to senior management effectively.
- Provide strategic technical leadership and drive program acceleration with risk/cost management.
- Represent quality control in interactions with senior management and external stakeholders.
- Maintain a thorough understanding of impact and mitigation for project teams and quality directives.
Who You Are:
You are a strategic thinker with a deep understanding of quality control processes and compliance requirements. Your ability to communicate effectively and escalate risks will set you apart in this role. You thrive in ambiguous situations and have a knack for guiding experimental approaches. Your leadership skills enable you to mentor others, driving the team towards achieving departmental objectives. You are detail-oriented yet able to see the big picture, balancing cost with value in strategic decision-making.
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Required Skills:
- B.S or M.S. degree (preferably in Life Science and management).
- At least 7 years of relevant experience in pharmaceutical or biotech manufacturing environment.
- Experience with regulatory audits, quality systems, business processes, and project management.
- Strong risk management skills and ability to develop measurable improvements.
- Effective communication and leadership competencies.
- Proven ability to manage complex problems and mentor others effectively.
Preferred Skills:
- Experience in financial planning and contract management.
- Familiarity with Vision 2030 objectives and strategic work relationships.
- Background in managing external testing operations and process innovation.
Job Level: Management
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 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.
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)