Quality Lead, Manager

🔥 11 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Manager

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Manage all aspects related to product quality and compliance for a portfolio of external contract manufacturers and suppliers delivering materials and/or products to Pfizer, in accordance with established procedures • Assess the quality of external suppliers’ products, manufacturing processes, and related documentation, ensuring product specifications are met and quality systems are maintained • Support internal and external partners with auditing activities related to ESOQ operations and contractor portfolios, including RQA audits and regulatory inspections, as applicable • Support internal and external partners with Compliance Assessments to ensure ongoing GMP/GDP adherence • Manage vendor risk by implementing Quality Improvement Plans and supporting risk assessments, Quality Review Teams (QRTs), and Quality Action Notices (QANs), as required • Support onboarding activities for new CMOs and product launches within the assigned portfolio • Support offboarding activities for exiting CMOs, products, or SKUs within the portfolio • Make product quality decisions by leveraging comprehensive knowledge of Quality and Manufacturing principles, prior work experience, and technical expertise, while ensuring compliance with global regulatory and Pfizer requirements • Influence quality decision‑making in alignment with industry standards and Pfizer requirements • Provide Quality leadership within cross‑functional Virtual Site Operating Teams (VSOTs) • Partner with colleagues to develop, review, and negotiate Quality Agreements • Review and approve Annual Product Reviews (APR), Product Quality Reviews (PQR), and relevant product stability reports • Perform batch disposition endorsement in accordance with Pfizer requirements • Identify, develop, and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with evolving internal and external standards • Ensure accurate tracking, documentation, and escalation of all required quality‑related actions in the relevant systems • Lead and support complex investigations, market complaints, and risk assessments for products within the portfolio; raise NTMs and engage SMEs as needed • Provide performance metrics and reporting for key quality performance indicators • Work independently, receiving guidance primarily on unusual or complex issues • Build, maintain, and further develop strong relationships with key internal and external stakeholders

🎯 Requirements

• Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline • Minimally 5 years’ experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 10 years’ experience in the pharmaceutical or medical device industry • Experience with external suppliers/contractors • Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, eQMS • Proficient in English and technical writing • Strong verbal, written communication, and presentation skills • Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives • Demonstrated experience managing complex quality and compliance activities • Problem solving attitude and open to innovation • Demonstrated managerial/organizational skills • Strong critical thinking and proactive, persistent approach • Good organizing and planning skills and a high sense of urgency • Demonstrated ability to act and work independently, to take initiative and to report items as required to line manager • Demonstrated knowledge of US, European and global cGxPs, compliance issues, inspectional trends, industry quality assurance practices • Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives • Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role

🏖️ Benefits

• Flexible working hours • Professional development opportunities