Quality Auditor III
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Job Location:
Andover, KS - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in Andover MA is currently looking for an Quality Auditor III to join their expanding team.
Job Title: Quality Auditor III / Pharma External Manufacturing
Duration: 15 months contract extendable up to 48 months
Location: Andover MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Our client a world-leading Pharmaceutical Company in Andover MA is currently looking for an Quality Auditor III to join their expanding team.
Job Title: Quality Auditor III / Pharma External Manufacturing
Duration: 15 months contract extendable up to 48 months
Location: Andover MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
External Supply Operations Quality (ESOQ Manager)
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 client 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.
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 client 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.
Responsibilities:
The ESOQ Manager holds overall accountability for assigned CMOs with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
The ESOQ Manager is accountable for providing quality assurance management of key contractors for client and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs the registration file and any additional country specific requirements.
This is highly independent position operating with minimal supervision interacting with high levels of management both at contract manufacturers and within client.
(S)he will operate as spokesperson for ESOQ and will focus on developing relationships independently negotiating developing and communicating client quality requirements with contract manufacturers.
ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply Regulatory Technical Support Quality PGS sites and R&D) and will lead virtual cross functional teams.
Initiate review and approve regulatory changes through client enterprise system (i.e. PDM) for changes initiated by or impacting ESOQ managed contractors.
Provide support for the closure of the deficiency letters CMC Commitments Regulatory requests for Renewals New Product Registrations and Post approval variations.
Main point of contact for Global Chemistry Manufacturing & Controls (CMC) or Local Regulatory Affairs in client Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
As the Quality & Regulatory Expert participate in Virtual Site Operating Teams (VSOT) for ESOQ managed contractors and if needed participate in Site Quality visits at the contractors.
Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).
The ESOQ Manager holds overall accountability for assigned CMOs with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
The ESOQ Manager is accountable for providing quality assurance management of key contractors for client and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs the registration file and any additional country specific requirements.
This is highly independent position operating with minimal supervision interacting with high levels of management both at contract manufacturers and within client.
(S)he will operate as spokesperson for ESOQ and will focus on developing relationships independently negotiating developing and communicating client quality requirements with contract manufacturers.
ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply Regulatory Technical Support Quality PGS sites and R&D) and will lead virtual cross functional teams.
Initiate review and approve regulatory changes through client enterprise system (i.e. PDM) for changes initiated by or impacting ESOQ managed contractors.
Provide support for the closure of the deficiency letters CMC Commitments Regulatory requests for Renewals New Product Registrations and Post approval variations.
Main point of contact for Global Chemistry Manufacturing & Controls (CMC) or Local Regulatory Affairs in client Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
As the Quality & Regulatory Expert participate in Virtual Site Operating Teams (VSOT) for ESOQ managed contractors and if needed participate in Site Quality visits at the contractors.
Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).
Qualifications:
Minimally BA/BS Science Engineering or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role.
At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
Advanced computer skills MS Office and enterprise systems such as SAP QTS PDM Documentum platforms.
Command of English language required and multi-lingual is a benefit.
Strong verbal and written communication including presentation skills.
Shows strong negotiation skills and is diplomatic in communication with internal and external customers.
Demonstrated ability to manage multiple projects and priorities.
Demonstrated ability to prioritize work to act and work independently and to escalate items as required to Team leader.
Demonstrated excellent organization skills.
Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
Developing personal leadership to manage cross functional projects.
Developing ability to resolve conflicts.
Takes initiatives and is proactive persistent.
Has a broad GMP and technical know-how to handle emerging issues.
Able to report remotely and deliver work independently.
Up to 20% travel may be required.
Minimally BA/BS Science Engineering or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role.
At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
Advanced computer skills MS Office and enterprise systems such as SAP QTS PDM Documentum platforms.
Command of English language required and multi-lingual is a benefit.
Strong verbal and written communication including presentation skills.
Shows strong negotiation skills and is diplomatic in communication with internal and external customers.
Demonstrated ability to manage multiple projects and priorities.
Demonstrated ability to prioritize work to act and work independently and to escalate items as required to Team leader.
Demonstrated excellent organization skills.
Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
Developing personal leadership to manage cross functional projects.
Developing ability to resolve conflicts.
Takes initiatives and is proactive persistent.
Has a broad GMP and technical know-how to handle emerging issues.
Able to report remotely and deliver work independently.
Up to 20% travel may be required.
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- ISO 9001
- Quality Audits
- Process Mapping
- Fair Housing Regulations
- Quality Control
- Underwriting
- cGMP
- As9100
- Manufacturing
