Manager, Quality Control Jobs

Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham
Posted Date: Aug 7 2023

The Manager Quality Control is responsible for the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing of 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 analytical test 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 products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Participate in vendor and internal audits as needed
• Provide analytical support for manufacturing investigations as required
• Assist in the management of drug substance and drug product analytical testing at contract laboratories
• Investigate and resolve analytical test failures (OOS and atypical results)
• Contribute to company quality systems
• Assemble data packages in support of specification and method changes associated with GSK products
• Represent QC in cross-functional teams with internal and external customers
• Assist in the management of stability activities including data review and trend evaluation
• Review QC raw data and assist in batch release
• Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidance
• Other duties as assigned
• Review and approve various quality documents (internal and external) associated with GSK products
• Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports
• Assist in the preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports)

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Experience building relationships and working with CMOs
• BS in a scientific area
• Ability to travel (includes international), 10%
• 5+ years’ experience in the pharmaceutical/bio-pharm manufacturing industry with at least 1 of those years at the QC manager level
• Experience with analytical testing concepts, stability testing and current cGMPs including laboratory controls and good documentation practices

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Working knowledge of statistical analysis programs and software (e.g., JMP or Statistica) for performing trend analysis and reporting of stability data and metrics
• Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
• Competency in MS Office Products and Adobe Acrobat
• Independently motivated and detail oriented with good problem-solving ability
• Excellent written and oral communication skills
• Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts
• Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs

#LI-GSK

#CMCDevelopmentGSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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