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myGwork - LGBTQ+ Business Community · 3 days ago
R&D Validation Manager
King of Prussia, PA
Full-time
Onsite
Director
10+ years exp
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Responsibilities
Develop and implement strategy, policy and group objectives that build competency in operational validation of clinical products.
Accountable for building continuous improvement in to the processes and ways of working to optimize end to end quality and right first time.
Support R&D sites on operational validation reports and standards.
Responsible for the detection, communication and escalation of risks, and subsequent management of mitigation actions.
Responsible for governing system validation status by review and approve R&D operation processes validation review plans.
Assist in the implementation of Product Life Cycle management through Process Validation & Continued Process Verification at site. Accountable for team of global Quality Assurance managers, will motivate, focus and develop the team. In an inclusive environment to build a high performing team.
Responsible for representing Quality R&D on validation, providing relevant information to governance boards and one voice of GSK internally and externally.
Ensure a robust GxP training program, that appropriate qualification, validation and change control activities are undertaken within business partner areas.
Responsible for quality oversight, ensuring robust quality management systems are in place.
Participating in audits and assist in the CAPA design, and completion of CAPA actions where they sit with the validation team.
Qualification
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Required
Bachelor's degree
10+ years' experience in Quality function in a highly regulated environment (EMA/ FDA/ MHRA)
5 years in a quality management position in manufacturing or analytical testing and release
Preferred
Strong interpersonal skills with demonstrated ability to engage, empower and influence people
Strong leadership skills to motivate, engage and develop team capabilities
Ability to drive change and continuous improvement
In depth understanding of cGMP and regulations applicable to GSK in the relevant countries. (FDA/EU/WHO and other countries)
Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolution
Ability to work transversally in matrix organization, with global perspectives
Ability to make independent decisions even under pressure and navigate in grey zones
Ability to communicate complex information both orally and in writing
Ability to adapt, work under uncertainty and accommodate flexible work demands
Benefits
Health Insurance
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Leadership Team
Adrien Gaubert
Co-Founder & CMO
Recent News
2024-04-10
Company data provided by crunchbase
