Pierre Fabre
Associate Director, External Quality Operations
Pierre Fabre, Secaucus, New Jersey, us, 07094
Associate Director, External Quality OperationsYour mission
Associate Director, External Quality Operations
Pierre Fabre , the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.
Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology.
Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with
New Ways to Care .
Join Pierre Fabre Pharmaceuticals to make a real impact in people's lives. Your purposeful career begins here.
SUMMARY:
We are seeking an experienced, highly motivated, and well-organized Quality professional to join our fast-paced, growing Cell Therapy company. This position is responsible for External Quality Operations for Pierre Fabre Pharmaceuticals US - Cell Therapy (PFP). As the Manager / Associate Director of External Quality Operations, you will be responsible for supporting PFP’s contract manufacturing organizations (CMOs) ensuring the highest standards of quality and compliance across all aspects of our operations. The ideal candidate will partner with internal and external stakeholders to drive consistency, reliability and compliance across the CMO network; to ensure commercial product supply. Reporting to the Director of Quality Operations, you will collaborate closely with cross-functional teams to ensure seamless integration of quality processes throughout the organization.
KEY RESPONSIBILITIES:
The Quality Assurance Manager / Associate Director is the responsible Quality point of contact for the Contract Manufacturing Organizations (CMOs), providing direct support from a quality and compliance perspective.
The Quality Assurance Manager / Associate Director coordinates oversight of all quality interactions with CMOs and serves as the quality representative in both internal core team meetings and joint meetings with CMOs.
This role is responsible to ensure cGMP documents and records obtain and meet expectations for the required PFP review and approval in accordance with PFP procedures and any applicable regulatory requirements.
Core Responsibilities
Acts as the CMO Quality site contact and responsible for CMO quality oversight.
Quality representative actively engaged in internal core team meetings and joint meetings with CMOs.
Responsible for the quality oversight of cGMP documents and records (including, but not limited to, batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements, and product technical specifications).
Monitor CMO performance to establish key performance indicators (KPIs) and report and escalate adverse trends.
Ensure adequate remediation plan to improve KPIs as well as risk ranking outcomes.
Demonstrate understanding of applicable health authority regulations related to manufacture of cell therapy products.
Partner with internal stakeholders to review and approve investigations for deviations, non-conformances, and customer complaints, ensuring thorough root cause analyses and applicable corrective and preventive actions (CAPA) are in place.
Support the internal and external audit program, including participating in regulatory inspections and managing responses.
Enter and review, approve and/or validate data into relevant data consolidation platforms, as needed.
Continuous Improvement and Training:
Process Optimization : Drive a culture of continuous improvement and proactively identify opportunities for efficiency enhancements and process improvements within the Quality Operations workflows.
Training and Mentorship : Provide training and mentorship to internal and external partners on batch release processes and documentation requirements.
Quality Culture : Promote a culture of quality and compliance across the organization by advocating for best practices and continuous improvement.
REQUIRED EDUCATION AND EXPERIENCE:
Basic Qualifications:
Bachelor's degree and 8-12 years of related pharmaceutical/biopharmaceutical work experience or master’s degree and 6-8 years of work experience.
Minimum of 5 years in management / leadership positions in a cGMP environment.
Aseptic processing experience is required.
Experience in commercial manufacturing required.
Up to 25% travel, domestic and international.
Demonstrated ability to partner and build trust, cultivating positive working relationships with CMO(s). Effectively communicate changes and resolve issues with CMOs in partnership with internal and external stakeholders. Lead and/or participate in cross-functional projects to promote company objectives.
Skills and Abilities
Authentic leader, ability to actively serve, collaborate, and develop relationships in and outside the organization. Strong knowledge of US and EU cGMP regulations/guidance. Ability to aseptically gown and navigate cleanroom manufacturing areas. Excellent written and oral communication skills. Strong analytical and problem-solving skills; great attention to detail and the ability to drive timely and fact-based decision making. Ability to function in a rapidly changing environment & handle multiple priorities. Ability to travel as needed to support on-site workshops, review and release requirements, manufacturing activities, etc.
Preferred Qualifications:
In depth working knowledge of cGMP Quality Systems (change management, discrepancy management, corrective and preventive measures, and validation). Demonstrated ability to manage cross-functional teams and inspire collaboration across the business. Preferred experience in cell and/or gene therapy operations and contract manufacturing.
LOCATION:
Hybrid - Secaucus, NJ; Remote option will be considered with some travel (15%) to NJ office as needed
Benefits of being a Pierre Fabre Employee:
Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees.
Pierre Fabre
Pierre Fabre has been recognized by Forbes as one of the
World's Best Employers
for the 3rd year running.
True to My Nature
Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#J-18808-Ljbffr
Associate Director, External Quality Operations
Pierre Fabre , the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.
Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology.
Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with
New Ways to Care .
Join Pierre Fabre Pharmaceuticals to make a real impact in people's lives. Your purposeful career begins here.
SUMMARY:
We are seeking an experienced, highly motivated, and well-organized Quality professional to join our fast-paced, growing Cell Therapy company. This position is responsible for External Quality Operations for Pierre Fabre Pharmaceuticals US - Cell Therapy (PFP). As the Manager / Associate Director of External Quality Operations, you will be responsible for supporting PFP’s contract manufacturing organizations (CMOs) ensuring the highest standards of quality and compliance across all aspects of our operations. The ideal candidate will partner with internal and external stakeholders to drive consistency, reliability and compliance across the CMO network; to ensure commercial product supply. Reporting to the Director of Quality Operations, you will collaborate closely with cross-functional teams to ensure seamless integration of quality processes throughout the organization.
KEY RESPONSIBILITIES:
The Quality Assurance Manager / Associate Director is the responsible Quality point of contact for the Contract Manufacturing Organizations (CMOs), providing direct support from a quality and compliance perspective.
The Quality Assurance Manager / Associate Director coordinates oversight of all quality interactions with CMOs and serves as the quality representative in both internal core team meetings and joint meetings with CMOs.
This role is responsible to ensure cGMP documents and records obtain and meet expectations for the required PFP review and approval in accordance with PFP procedures and any applicable regulatory requirements.
Core Responsibilities
Acts as the CMO Quality site contact and responsible for CMO quality oversight.
Quality representative actively engaged in internal core team meetings and joint meetings with CMOs.
Responsible for the quality oversight of cGMP documents and records (including, but not limited to, batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements, and product technical specifications).
Monitor CMO performance to establish key performance indicators (KPIs) and report and escalate adverse trends.
Ensure adequate remediation plan to improve KPIs as well as risk ranking outcomes.
Demonstrate understanding of applicable health authority regulations related to manufacture of cell therapy products.
Partner with internal stakeholders to review and approve investigations for deviations, non-conformances, and customer complaints, ensuring thorough root cause analyses and applicable corrective and preventive actions (CAPA) are in place.
Support the internal and external audit program, including participating in regulatory inspections and managing responses.
Enter and review, approve and/or validate data into relevant data consolidation platforms, as needed.
Continuous Improvement and Training:
Process Optimization : Drive a culture of continuous improvement and proactively identify opportunities for efficiency enhancements and process improvements within the Quality Operations workflows.
Training and Mentorship : Provide training and mentorship to internal and external partners on batch release processes and documentation requirements.
Quality Culture : Promote a culture of quality and compliance across the organization by advocating for best practices and continuous improvement.
REQUIRED EDUCATION AND EXPERIENCE:
Basic Qualifications:
Bachelor's degree and 8-12 years of related pharmaceutical/biopharmaceutical work experience or master’s degree and 6-8 years of work experience.
Minimum of 5 years in management / leadership positions in a cGMP environment.
Aseptic processing experience is required.
Experience in commercial manufacturing required.
Up to 25% travel, domestic and international.
Demonstrated ability to partner and build trust, cultivating positive working relationships with CMO(s). Effectively communicate changes and resolve issues with CMOs in partnership with internal and external stakeholders. Lead and/or participate in cross-functional projects to promote company objectives.
Skills and Abilities
Authentic leader, ability to actively serve, collaborate, and develop relationships in and outside the organization. Strong knowledge of US and EU cGMP regulations/guidance. Ability to aseptically gown and navigate cleanroom manufacturing areas. Excellent written and oral communication skills. Strong analytical and problem-solving skills; great attention to detail and the ability to drive timely and fact-based decision making. Ability to function in a rapidly changing environment & handle multiple priorities. Ability to travel as needed to support on-site workshops, review and release requirements, manufacturing activities, etc.
Preferred Qualifications:
In depth working knowledge of cGMP Quality Systems (change management, discrepancy management, corrective and preventive measures, and validation). Demonstrated ability to manage cross-functional teams and inspire collaboration across the business. Preferred experience in cell and/or gene therapy operations and contract manufacturing.
LOCATION:
Hybrid - Secaucus, NJ; Remote option will be considered with some travel (15%) to NJ office as needed
Benefits of being a Pierre Fabre Employee:
Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees.
Pierre Fabre
Pierre Fabre has been recognized by Forbes as one of the
World's Best Employers
for the 3rd year running.
True to My Nature
Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#J-18808-Ljbffr