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 escalating 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.

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.

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