M
Clinical and Health - QA Auditor II
Mindlance
- 🇺🇸 United States
- On-site
- 1 day ago
- GMP
- CAPA
- Microsoft Office Applications
- Excel
- PowerPoint
- Outlook
1 day ago
Functional Service Provider (FSP) Function Quality R&D Third Party Engagement Type Functional Service Provider (FSP) Primary Interface Third Party Quality Director or designated GSK Quality Senior Lead
Role Overview
An opportunity has arisen for a Third Party Quality Lead to support the Quality R&D Third Party organization. The worker will provide quality oversight for external third parties supporting GMP manufacture of active pharmaceutical ingredient (API), cell banking (CB), drug substance (DS), and drug product (DP) for R&D programs.
The successful candidate will play a key role in ensuring that contracted services and associated batch documentation meet applicable GMP, regulatory, GSK quality, and quality agreement requirements. The role also provides the opportunity to apply third-party quality management expertise in a cross-functional R&D environment.
Key Responsibilities
Responsibilities include some of the following:
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Act as the primary day-to-day quality contact for assigned third parties and projects, working with internal stakeholders involved in activities contracted to those third parties.
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Monitor and support management of third-party quality performance and compliance with applicable GSK standards, quality requirements, current Good Manufacturing Practice (cGMP), regulatory requirements, and quality agreements.
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Coordinate and support quality governance meetings with assigned third parties, including preparation of quality performance information, documentation of actions, and follow-up to closure.
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Draft, coordinate, review, maintain, and support approval of quality agreements and related quality documentation, as applicable.
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Review and assess third-party quality management system records, including deviations, complaints, change controls, corrective and preventive actions (CAPAs), investigations, and validation-related documentation, and ensure timely follow-up in accordance with cGMP and quality agreements.
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Identify, assess, document, communicate, mitigate, and escalate quality issues and risks through the appropriate GSK quality governance pathways.
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Review and approve, or provide quality recommendations on, documentation required to support batch disposition/release activities within the scope of the engagement and applicable authorization.
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Ensure documentation associated with assigned third parties is appropriately reviewed, managed, retained, and archived in accordance with applicable requirements.
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Support third-party selection, qualification, approval, and maintenance of approval status, as appropriate to the assigned scope.
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Participate in third-party audit planning, preparation, execution, response follow-up, and CAPA oversight, as applicable.
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Provide quality support for product or process transfers between GSK and third parties and for other assigned external manufacturing activities.
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Develop, implement, and improve effective processes and procedures within Quality R&D Third Party, and contribute to cross-functional process improvement initiatives.
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Provide training, education, guidance, and quality advice to business partners and third parties on relevant quality and compliance expectations.
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
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Bachelor's degree in Pharmacy, Science, Engineering, or a related discipline, or an equivalent level of knowledge, understanding, and hands-on GMP experience in the pharmaceutical environment.
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At least 5 years of pharmaceutical manufacturing and/or quality experience.
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Practical knowledge of cGMP principles and regulatory expectations applicable to pharmaceutical development and manufacturing.
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Experience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.
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Experience supporting or leading quality system activities such as deviations, investigations, complaints, change controls, CAPAs, inspections, audits, and root-cause analysis.
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Experience working with external manufacturing organizations, suppliers, service providers, or other third parties.
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Ability to make sound, risk-based quality decisions and escalate issues appropriately.
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Proficient working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
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Experience providing quality oversight for contract manufacturing organizations supporting API, cell banking, drug substance, drug product, or investigational medicinal products.
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Knowledge of the pharmaceutical R&D lifecycle, including clinical development manufacturing and technology transfer.
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Experience with batch documentation review and disposition/release support.
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Experience with quality agreements, third-party quality governance, quality performance monitoring, and supplier qualification.
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Ability to work independently, manage competing priorities, and consistently deliver agreed outputs in a matrixed and deadline-driven environment.
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Excellent written and verbal communication skills, with the ability to build effective working relationships and influence internal and external stakeholders.
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Strong attention to detail, analytical thinking, problem identification, and problem-solving skills.
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Experience working effectively with cross-functional and geographically dispersed teams and supporting continuous improvement initiatives.
Working Relationships
The worker will collaborate with Quality R&D Third Party, R&D project teams, technical and supply functions, regulatory and clinical supply partners, procurement or third-party management functions, and external manufacturing or service providers, as applicable to the assigned work package.
Monday to Friday - First Shift / 40 hours full time onsite
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Clinical and Health - QA Auditor II · Mindlance