Quality Assurance Manager - Drug Product

Gsk Plc

7+ years

Not Disclosed

Marietta

10 Jan. 17, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Manager – GSK
Location: USA – Pennsylvania – Marietta
Posted Date: October 24, 2024

Are you driven by a technical role that uses cutting-edge quality assurance technology and method development? If so, the Quality Assurance (QA) Manager position at GSK could be the perfect opportunity for you.

In this role, you will lead and build the QA team to ensure the successful transfer of Drug Product processes and test methods to the Marietta site, adhering to GSK and GMP guidelines. Additionally, you will provide direct support for initial start-up activities and maintain a strong focus on excellence in quality assurance leadership.

Key Responsibilities:

Lead QA oversight during the project phase, driving quality direction for Drug Product processes and testing through operational readiness.
Provide QA oversight of validation program execution, collaborating with project teams and other QA departments across GSK sites to align strategies.
Support regulatory applications and filings with QA expertise.
Ensure that all Drug Product systems and processes are maintained in a validated state throughout their lifecycle, focusing on policy administration and issue resolution.
Participate in optimization and improvement initiatives and provide QA support during regulatory inspections.
Oversee and approve system and process lifecycle documentation, including risk and impact assessments, specifications, protocols, validation plans, and reports.
Review, approve, and generate QA documentation for operational readiness objectives and manufacturing operations in a cGMP regulated facility.
Ensure quality objectives are met within the set timelines, collaborating across sites to maximize efficiency.
Lead effective verbal and written communication while forming productive relationships with teams at all levels.

Basic Qualifications:

Bachelor’s Degree in Chemistry, Biochemistry, Microbiology, or a related scientific discipline.
7+ years of managerial experience in the pharmaceutical industry, specifically in QA, QC, Regulatory, or Operations.

Preferred Qualifications:

Lean / Six Sigma training and certification.
Certification or training in quality systems or cGMP compliance from a recognized organization such as ASQ.
In-depth knowledge of GMPs, NIH guidelines, FDA, and other regulatory agency requirements for quality operations.
Strong technical understanding of industry and scientific practices related to biopharmaceutical production.
Excellent communication, problem-solving, and interpersonal skills, with the ability to influence teams and stakeholders.
Experience with risk management principles and cross-functional leadership.
High learning agility and the ability to drive results in a fast-paced environment.

Why GSK?
GSK is a global biopharma leader with a mission to unite science, technology, and talent to get ahead of disease. Join us in our journey to positively impact the health of billions and create a workplace where people can thrive. At GSK, we are dedicated to making sure our team members feel valued, supported, and empowered to succeed.

Benefits:
GSK offers a comprehensive benefits package. Learn more on the GSK US Benefits Summary page.

Application Instructions:
Submit your application by November 3, 2024. Please include a detailed CV or cover letter demonstrating your experience and qualifications for this role.

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Quality Assurance Manager - Drug Product

Job Description

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