Manager - Contractor Quality Operations

il y a 2 jours

Zaventem, Belgique Pfizer Temps plein

Role Description

Reports to ESOQ Quality Operations Lead (Team Leader).

Actively contributes as part of the ESOQ Tier2 structure to ensure that Pfizer network of External suppliers / CMOs / partners is supported to deliver high-quality products, on time, and in compliance with all established standards and agency guidelines/ applicable GMP regulations.

As a Manager, the advanced and comprehensive knowledge of the principles and concepts of GMP and of other disciplines will enable the function to lead complex projects across the division.

Responsible for
- Managing all aspects related to product quality or compliance for a complex portfolio of external contract manufacturers and suppliers that supply Product(s) globally
- Assess the quality of external supplier’s products, processes, and related documents while ensuring the product specifications are met and quality systems are maintained.
- Supporting internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA audits or regulatory inspections) as applicable
- Supporting internal and external partners with Compliance Assessments to ensure current GMP adherence
- Make product Quality decisions leveraging advanced knowledge of quality/Manufacturing principles, prior work experience, and concepts in other technical areas while ensuring compliance with global regulatory and Pfizer requirements.
- Have the ability to lead and influence quality decision-making across all levels of the organization and with our external partners.
- Provide Quality Leadership within the cross-functional virtual site operating teams (VSOT).
- On-time disposition of Product.
- Identify, develop, and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
- Ensuring the adequate tracking and documentation of all required quality-related actions in the relevant system(s) and ensuring that all required escalation processes are followed.
- Leading and supporting complex investigations, market complaints, and risk assessments in support of products within your portfolio. Connect with SMEs where needed
- Working independently and operating with mínimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
- Building, maintaining, and developing relationships with key stakeholders, both internal and external to Pfizer.
- Supporting the development, implementation, and continuous improvement of innovative Quality Systems.

**Qualifications**:

- Must-Have_
- Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline
- Minimally 10 years of experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 15 years experience in the pharmaceutical or medical device industry.
- Advanced computer skills in MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms, Minitab
- Proficient in English (written and spoken)
- Strong technical writing skills
- Strong verbal, written communication, and presentation skills
- Demonstrated personal leadership to work in virtual teams and cross-functional projects/initiatives
- Demonstrated DEI attitude
- Is diplomatic, clear & succinct in communication with internal and external stakeholders
- Demonstrated experience managing complex quality and compliance activities
- Demonstrated experience managing priorities
- Demonstrated managerial/organizational skills
- Self-motivator & proven ability to lead independently
- Takes initiative and is proactive, persistent
- Strong organizing and planning skills and a high sense of urgency.
- Demonstrated knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices
- Demonstrated technical know-how
- Nice-to-Have_
- Master’s degree and + 15 years of relevant pharmaceutical experience.
- Demonstrated experience in aseptic manufacturing and other pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage) applicable to the role
- Experience with external suppliers/contractors
- Demonstrated investigation skills and knowledge of DMAIC, 6sigma, YB or GB - Knowledge of ImEx

Work Location Assignment: Flexible
- Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story._
- Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research cent

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