GlaxoSmithKline Manager, Quality Control - Stability, Strategic External Development in Waltham, Massachusetts
Manager, Quality Control – Stability, Strategic External Development
The Manager is responsible for supporting execution, harmonization, and integration of stability-related activities in compliance with QC processes, internal policies, procedures, and regulatory requirements. This includes supervision of stability data management and stability-related documentation (protocols, regulatory submissions, reports, and trending). This includes leading or assisting with improvement initiatives supporting robustness and harmonization of processes across sites in close collaboration with GSK Stability functions. Oversight of stability program for development pharmaceutical products and Active Pharmaceutical Ingredients (API) in support of GSK’s small molecule and/or immuno-oncology programs. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of stability reports or certificates. This includes assisting with QC checks and preparation of regulatory filings (IND, BLA and NDA), and manage projects associated with drug substance and drug product stability.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Assist in the management of stability related activities at contract laboratories.
Works with product teams to investigate and troubleshoot test failures related to stability testing (OOS, OOT’s and atypical results).
Ensures appropriate compliance with stability policies, regulations, procedures, and protocols.
Represent QC Stability in cross-functional teams with internal and external customers
Assist in the preparation of stability and reference standard sections of regulatory filings (Supplements and Annual Reports)
Assist with creation, review and revision of stability protocols and reports, and participate in stability strategy and protocol design.
Assist with harmonization and integration of stability-related activities.
Monitor and maintain internal stability schedules for GMP drug substance and drug product.
Review stability data, trending and reports for compliance and eventual inclusion in regulatory submissions.
Manage all quality systems owned by QC Stability and ensure on-time closures.
Review and approve various quality documents (internal and external) associated with GSK products
Provide stability support for manufacturing investigations as required
Participate in vendor and internal audits as needed
Contribute to company quality systems
Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidance’s.
Other duties as assigned
We are looking for professionals with these required skills to achieve our goals:
BS in a scientific area
5+ years’ experience in the pharmaceutical/bio-pharm manufacturing industry with at least 1 of those years at the QC manager level
1+ years’ experience with analytical testing concepts, stability testing and current cGMPs including laboratory controls and good documentation practices
1+ years’ experience building relationships and working with CMOs
Ability to travel (includes international), 10%
If you have the following characteristics, it would be a plus:
Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts
Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
Working knowledge of statistical analysis programs and software (e.g., JMP or Statistica) for performing trend analysis and reporting of stability data and metrics
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
Excellent written and oral communication skills
Competency in MS Office Products and Adobe Acrobat
Independently motivated and detail oriented with good problem-solving ability
Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
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