Sr Associate II Quality Control External Testing Management
Sr Associate II Quality Control External Testing Management
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Salary Not Disclosed
1 Vacancy
Job Description
About This Role
Biogen is seeking a dynamic professional to oversee all activities related to external Quality testing with a focus on managing Contract Laboratory Organizations (CLOs). This role drives the development and upkeep of key agreementsincluding Quality Agreements MSAs and SOWswhile leading RFPs purchase orders budget tracking and timeline oversight for outsourced testing. Youll be the project manager across multiple teams ensuring alignment on testing status resolving deviations and contributing to strategic initiatives like Annual Product Reviews and business performance evaluations. Reporting into Quality Control leadership youll collaborate crossfunctionally with Procurement Finance Quality Supply Chain and more playing a vital role in maintaining compliance and optimizing vendor performance. This is a highimpact role for someone who thrives on coordination communication and continuous improvement in a complex matrix environment.
What Youll Do
- Lead the development negotiation and maintenance of Quality Agreements Master Service Agreements and Statements of Work with Contract Laboratory Organizations (CLOs)
- Manage financial aspects of external testing including purchase order creation spend tracking and budgeting / budget reforecasting
- Monitor progress of outsourced testing activities ensure timely delivery of results and communicate status updates across functional teams
- Investigate and resolve testing exceptions deviations and compliance issues related to CLO activities
- Serve as the primary Quality point of contact for CLO performance monitoring issue escalation and business reviews
- Actively participate in programlevel Asset and/or Quality SubTeam meetings to represent external testing interests
- Collaborate crossfunctionally with Procurement Finance Corporate Quality Auditing QC Analytical Technology and Supply Chain Planning
- Support Annual Product Review by contributing CLOrelated performance data and testing summaries
- Identify and implement process improvements to enhance efficiency compliance and communication across CLO operations
- Ensure robust information management and documentation practices to support audit readiness and regulatory compliance
Who You Are
You are a skilled communicator and organized project manager with experience overseeing external lab testing in a regulated pharmaceutical environment. You thrive in crossfunctional settings excel at managing vendors and contracts and demonstrate strong attention to detail when managing compliance timelines and continuous improvement.
Qualifications :
Required Skills
- Bachelors degree plus minimum of 5 years of experience working in a cGMP Biotech/pharma Quality Control environment OR biotech/pharma finance environment
- Previous experience in contract and/or vendor management
- Project management skills
- Deep understanding of quality and compliance
- Demonstrated crossfunctional collaboration abilities
- Strong verbal and written communication skills and information management skills
Preferred Skills
- Experience using the following software/programs: Veeva Oracle PLM Excel OneNote
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
