Porton USA, LLC
GMP Compliance Manager or Associate Director
Porton USA, LLC, East Brunswick, New Jersey, United States,
Job Title:
GMP Compliance Manager or Associate Director
Job Location:
Cranbury & South Plainfield NJ
Direct Report:
Head of Quality Assurance
Job Summary:
This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance. This role will also promote and drive compliance by building inspection readiness processes across the organization. This individual will also play a leading role in the preparation and execution of regulatory inspections, client audits, and internal audits, as well as follow up post audit/inspection on any items requiring response and action. Specific responsibilities of the position include, but are not necessarily limited to, the items listed below.
Primary Responsibilities:
Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization.
Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory requirements and trends.
Supporting regulatory inspections and client audits in creating, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all times.
Responding to incoming enquiries during inspections and audits and ensuring timely and accurate responses.
Evaluating outcomes of regulatory authority inspections/client audits to identify near misses, lessons learned and other best practices and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented.
Establishing and maintaining a communication process mechanism to supervisor on the status of inspection readiness and CAPA commitments.
Evaluating and managing proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.
Work collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirm their timely closure and ensure suitable effectiveness checks are in place.
Generating, developing and reporting metrics/trends for program adherence to requirements and effectiveness.
Revise SOPs and quality system designs to implement practices and improvements to make sure site inspection-ready at all times.
Manage and review deviations, change controls, and CAPAs including providing metrics and trending of relevant data.
Building and implementing tools to improve site inspection readiness; determine system improvements through effective project management.
Participating in internal committees/teams, as required.
Cross-site support of inspection readiness and inspection activities.
Other QA duties assigned by supervisor.
Qualifications:
Education:
A minimum of a Bachelor’s degree in a scientific discipline or equivalent experience.
Experience:
Minimum of 5-7 years of experience in GMP compliance within the CDMO or pharmaceutical industry. This role will be considered at different levels depending on experience.
Technical Skills:
Rich knowledge of GMP guidelines, such as ICH Q7, Q9, Q10, etc. and regulatory requirements, such as CFR 21, part 210, 211, and 11. Proficient in using Microsoft Office.
Job Type:
Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance
Schedule:
Monday to Friday
Experience:
GMP Compliance: 5 years (Required)
Ability to Commute:
East Brunswick, NJ (Required)
Ability to Relocate:
East Brunswick, NJ: Relocate before starting work (Required)
Work Location:
In person
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GMP Compliance Manager or Associate Director
Job Location:
Cranbury & South Plainfield NJ
Direct Report:
Head of Quality Assurance
Job Summary:
This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance. This role will also promote and drive compliance by building inspection readiness processes across the organization. This individual will also play a leading role in the preparation and execution of regulatory inspections, client audits, and internal audits, as well as follow up post audit/inspection on any items requiring response and action. Specific responsibilities of the position include, but are not necessarily limited to, the items listed below.
Primary Responsibilities:
Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization.
Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory requirements and trends.
Supporting regulatory inspections and client audits in creating, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all times.
Responding to incoming enquiries during inspections and audits and ensuring timely and accurate responses.
Evaluating outcomes of regulatory authority inspections/client audits to identify near misses, lessons learned and other best practices and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented.
Establishing and maintaining a communication process mechanism to supervisor on the status of inspection readiness and CAPA commitments.
Evaluating and managing proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.
Work collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirm their timely closure and ensure suitable effectiveness checks are in place.
Generating, developing and reporting metrics/trends for program adherence to requirements and effectiveness.
Revise SOPs and quality system designs to implement practices and improvements to make sure site inspection-ready at all times.
Manage and review deviations, change controls, and CAPAs including providing metrics and trending of relevant data.
Building and implementing tools to improve site inspection readiness; determine system improvements through effective project management.
Participating in internal committees/teams, as required.
Cross-site support of inspection readiness and inspection activities.
Other QA duties assigned by supervisor.
Qualifications:
Education:
A minimum of a Bachelor’s degree in a scientific discipline or equivalent experience.
Experience:
Minimum of 5-7 years of experience in GMP compliance within the CDMO or pharmaceutical industry. This role will be considered at different levels depending on experience.
Technical Skills:
Rich knowledge of GMP guidelines, such as ICH Q7, Q9, Q10, etc. and regulatory requirements, such as CFR 21, part 210, 211, and 11. Proficient in using Microsoft Office.
Job Type:
Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance
Schedule:
Monday to Friday
Experience:
GMP Compliance: 5 years (Required)
Ability to Commute:
East Brunswick, NJ (Required)
Ability to Relocate:
East Brunswick, NJ: Relocate before starting work (Required)
Work Location:
In person
#J-18808-Ljbffr