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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:
Why you? Basic Qualifications:
- Assist in the management of drug substance and drug product analytical testing at contract laboratories
- Assist in the management of stability activities including data review and trend evaluation.
- Investigate and resolve analytical test failures (OOS and atypical results)
- Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports
- Review QC raw data and assist in batch release.
- 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 preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports)
- Review and approve various quality documents (internal and external) associated with GSK products
- Provide analytical 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 guidances.
- 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
- Experience with analytical testing concepts and current cGMPs including laboratory controls and good documentation practices
- 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
- 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
Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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