The Contractor Quality Lead manages product quality and compliance for external contract manufacturers, ensuring adherence to GMP standards and leading quality initiatives.
Role Description:
The Global External Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."
External Supply Operations Quality (ESOQ) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.
ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.
As a Senior 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 and support /back up the ESOQ Quality Operations Team Lead as needed. Some regional specific roles may have region specific responsibilities.
Accountabilities
Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer network of External suppliers / CMO's / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/ applicable GMP regulations.
Responsibilities:
Manage 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.
Support 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
Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence
Manage Risk at Vendors implementing Quality Improvement Plans and support Risk assessments, QRTs and QANs as necessary
Support onboarding activities of new CMO's or product launches within the portfolio as applicable.
Support offboarding activities for exiting CMO's/products/SKUs within the portfolio as applicable
Make product Quality decisions leveraging advanced knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.
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).
Partner with colleagues to develop and negotiate quality agreements.
Review and approve Annual Product Review and Product Quality Review (APR/PQR) reports and relevant product stability reports.
Perform batch disposition endorsement.
Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed.
Lead and support complex investigations, market complaints, risk assessments and others in support of products within your portfolio. Raise NTMs and connect with SMEs where needed.
Provide Performance Metrics for key performance indicators.
Work independently and operate with minimal supervision, interact with high levels of management both at contract manufacturers and within Pfizer.
Build, maintain and develop relationships with key stakeholders, both internal and external to Pfizer.
Support the development, implementation and continuous improvement of innovative Quality Systems.
Be a resource for manager level colleagues on the team and peers in External Supply Quality and be able to provide directions to peers including risk-based decision making and innovative solutions to ambiguous problems.
Develop ideas and lead complex crossfunctional project teams including internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D), anticipate potential challenges the team may encounter, and be responsible for the team's deliverables and milestones.
Show interest in Innovation and innovative approaches.
Support ESOQ leadership in other tasks as required.
Support and act as back up of the team Site Quality Operations Lead as required.
If applicable:
Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers (CMO), contract testing organizations (CTO) and suppliers that supply materials/product(s) to Pfizer according to established procedures.
Creation of Process Orders (POs) and support to define provisions within the SOW/MSA for QC testing execution at the CTO.
Ensure stability studies at CMO/CTO sites are conducted according to approved protocols and ICH guidance.
Qualifications:
Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline
Minimally 10 years' 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.
Experience with external suppliers/contractors.
Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms, Minitab
Proficient in English and technical writing
Strong verbal, written communication, and presentation skills
Demonstrated personal leadership to lead virtual teams and cross functional projects/initiatives
Is diplomatic, clear & succinct in communication with internal and external stakeholders
Demonstrated experience managing complex quality and compliance activities
Demonstrated ability to resolve conflicts
Demonstrated managerial/organizational skills
Self-motivator & proven ability to lead independently
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
Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives
Work Location Assignment: Hybrid
GJL: J090
Worker Type:
Regular
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
The Global External Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."
External Supply Operations Quality (ESOQ) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.
ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.
As a Senior 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 and support /back up the ESOQ Quality Operations Team Lead as needed. Some regional specific roles may have region specific responsibilities.
Accountabilities
Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer network of External suppliers / CMO's / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/ applicable GMP regulations.
Responsibilities:
Manage 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.
Support 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
Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence
Manage Risk at Vendors implementing Quality Improvement Plans and support Risk assessments, QRTs and QANs as necessary
Support onboarding activities of new CMO's or product launches within the portfolio as applicable.
Support offboarding activities for exiting CMO's/products/SKUs within the portfolio as applicable
Make product Quality decisions leveraging advanced knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.
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).
Partner with colleagues to develop and negotiate quality agreements.
Review and approve Annual Product Review and Product Quality Review (APR/PQR) reports and relevant product stability reports.
Perform batch disposition endorsement.
Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed.
Lead and support complex investigations, market complaints, risk assessments and others in support of products within your portfolio. Raise NTMs and connect with SMEs where needed.
Provide Performance Metrics for key performance indicators.
Work independently and operate with minimal supervision, interact with high levels of management both at contract manufacturers and within Pfizer.
Build, maintain and develop relationships with key stakeholders, both internal and external to Pfizer.
Support the development, implementation and continuous improvement of innovative Quality Systems.
Be a resource for manager level colleagues on the team and peers in External Supply Quality and be able to provide directions to peers including risk-based decision making and innovative solutions to ambiguous problems.
Develop ideas and lead complex crossfunctional project teams including internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D), anticipate potential challenges the team may encounter, and be responsible for the team's deliverables and milestones.
Show interest in Innovation and innovative approaches.
Support ESOQ leadership in other tasks as required.
Support and act as back up of the team Site Quality Operations Lead as required.
If applicable:
Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers (CMO), contract testing organizations (CTO) and suppliers that supply materials/product(s) to Pfizer according to established procedures.
Creation of Process Orders (POs) and support to define provisions within the SOW/MSA for QC testing execution at the CTO.
Ensure stability studies at CMO/CTO sites are conducted according to approved protocols and ICH guidance.
Qualifications:
Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline
Minimally 10 years' 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.
Experience with external suppliers/contractors.
Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms, Minitab
Proficient in English and technical writing
Strong verbal, written communication, and presentation skills
Demonstrated personal leadership to lead virtual teams and cross functional projects/initiatives
Is diplomatic, clear & succinct in communication with internal and external stakeholders
Demonstrated experience managing complex quality and compliance activities
Demonstrated ability to resolve conflicts
Demonstrated managerial/organizational skills
Self-motivator & proven ability to lead independently
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
Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives
Work Location Assignment: Hybrid
GJL: J090
Worker Type:
Regular
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
Top Skills
Documentum
Minitab
MS Office
Qts
SAP
Vault
Pfizer Dublin, Dublin, IRL Office
Grange Castle Business Park, Dublin, Ireland
Pfizer Kildare, Kildare, IRL Office
Pfizer Newbridge, Kildare, Ireland
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