We’re hiring for a QA Manager to join our Quality Assurance Integrated Process Team. You will report to the Associate Director, Quality Assurance Integrated Process Team, collaborate closely with our existing team of QA Managers and Senior Specialist, and play a key role in safeguarding product quality and patient safety. This opportunity is ideal for an experienced Quality professional who thrives in a fast‑paced, collaborative manufacturing environment and is committed to delivering safe, compliant products.
Responsibilities
Provide expert Quality input and subject‑matter insight across three manufacturing suites, supporting timely and effective issue resolution.
Serve as the Quality Representative on complex investigations, contributing to robust and compliant decision‑making processes.
Foster consistent product quality and patient safety by supporting batch review and Product Safety Incident Management activities.
Collaborate closely with team members, the Associate Director, Integrated Process Team colleagues, and shift teams to drive operational excellence.
Represent the Quality Assurance Integrated Process Team at Quality and cross‑functional tier meetings, ensuring alignment across functions.
Build and maintain strong relationships across Quality, Operations, and support functions for seamless collaboration.
Coach and mentor direct reports, supporting their development and upskilling through meaningful one‑on‑ones, mid‑year, and end‑of‑year reviews.
Work with team members to deliver Continuous Improvement projects, standard work initiatives, and comprehensive training programs.
Champion a safe, compliant, high‑performance, and inclusive culture within the team.
Drive the completion of key projects and support the site’s goals through effective teamwork.
Ensure day‑to‑day compliance with Current Good Manufacturing Practice/Good Documentation Practice activities, regulatory requirements, and corporate standards.
Uphold Data Integrity principles in all documentation and recordkeeping.
Participate in internal and external audits as auditee for assigned areas, contributing to quality assurance.
Lead or support quality‑related projects aimed at improving quality reporting measures.
Contribute to documentation review, investigation writing, and Corrective and Preventive Action management.
Liaise with Quality Specialists, Quality Assurance Lead, Qualified Person, and Business Area Specialists to resolve quality queries efficiently.
Influence and support compliance initiatives to enhance batch release performance and operational efficiency.
Ensure effective communication channels are established across teams and organizational levels.
Act as an advocate for continuous improvement within the Quality Management System.
Perform other duties as assigned in support of department and site priorities.
Skills & Qualifications
Degree or higher in a Science‑based discipline.
Minimum of 5 years’ experience in the pharmaceutical industry.
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