Director, QC Systems and Stability
Job Location:
Durham County, NC - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
About This Role:
As the Director of Global QC Systems and Stability you will be at the helm of a global quality control department that plays a critical role in supporting both manufacturing operations and release stability testing laboratories. Your leadership will guide the department in managing Contract Laboratory Management Planning and Scheduling QC Enterprise System Management (LIMS) Specification/Stability programs and Reference Standards and Qualified Materials (RSMQ) Teams. Building strategic relationships with Site Quality Operations key internal and external partners IT and Senior Leadership will be essential to support daily operations in both external and internal manufacturing environments.
You will harmonize and streamline processes maintain SmartQC and LabWare LIMS oversee global projects and implement specifications and stability strategies for biologics small molecules and oligonucleotides products. You will also oversee a global team responsible for monitoring QC method performance optimizing assay control trending and managing Qualified Materials Reference Standards Critical Reagents and cell-based materials essential for analytical testing.
This is a hybrid role to be based at our site in Research Triangle Park NC or Cambridge MA.
What Youll Do:
Identify define and drive strategy and improvement projects to maximize efficiency streamline processes and increase productivity in QC data systems and stability.
Staff senior-level QC personnel ensuring their training and performance align with GMP compliant Quality Control operations.
Oversee the development and maintenance of budget plans for Contract Laboratory Operations OpEx ($15-16MM).
Supervise activities at multiple Contract Laboratory Organizations (CLOs) supporting Biogen and Partner product testing ensuring operational readiness.
Lead a team to acquire qualify and maintain reference standards and qualified materials for global laboratory operations.
Provide leadership and guidance to technical and operational staff in developing and implementing specification and stability strategies for various product modalities.
Utilize appropriate statistical tools to evaluate and interpret stability data and guide the creation of stability reports and regulatory sections.
Serve as Business Process Owner (BPO) for Stability QMS and associated systems.
Perform other duties as assigned contributing to the departments overall success.
Who You Are:
You are a strategic thinker with a robust background in quality control management. Your ability to build and maintain strategic relationships is complemented by your leadership skills in guiding technical and operational teams. You possess a keen analytical mind capable of synthesizing complex data into actionable insights. Your interpersonal skills are strong enabling you to operate effectively within a global cross-functional environment. You thrive in a dynamic setting where you can drive efficiency and innovation.
Required Skills:
Bachelors degree (Advanced degree preferred) in related field with at least 12 years of experience in the pharmaceutical industry preferably within a scientific-related field.
Strong knowledge of regulatory compliance GMP and laboratory testing including troubleshooting and root cause investigations.
Comprehensive understanding of cGMPs GLPs and related global regulatory requirements.
Proven matrix leadership capability with effective verbal and written communication skills.
Strong analytical critical thinking and interpersonal skills.
Experience in utilizing statistical tools and methodologies to evaluate and interpret stability data.
Ability to synthesize technical information for senior management.
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 $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 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 onto 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.
Required Experience:
Director
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
