Associate Director, Quality Control

Associate Director, Quality Control

Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.

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 the Quality Control (QC) unit for Pierre Fabre Pharmaceuticals US - Cell Therapy (PFP).

As the Manager / Associate Director of Quality Control, you will be responsible for the oversight of a variety of analytical functions, including validation and testing, and reporting of in-process release and stability samples in an efficient and cGMP compliant manner.

You will be responsible for planning and coordination of sample shipment, receipt, and testing at Contract Test Labs (CTLs) to ensure on-time delivery and release of final drug product.

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 Manager / Associate Director of Quality Control is the responsible Quality Control point of contact for the Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs), providing direct support from a quality control perspective.
• The Manager / Associate Director of Quality Control coordinates oversight of all sample management activities between CMOs / CTLs and serves as the quality control representative in both internal core team meetings and joint meetings with CMOs / CTLs.
• 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 PFP liaison for Quality Control between CMOs and CTLs.
• Assists in troubleshooting of analytical methods and / or equipment as required.
• Authors, reviews, and / or approves data, standard operating procedures, certificates of analysis / conformance, analytical methods, protocols, and reports.
• Monitors, tracks, and publishes key performance indicators (KPIs) related to Quality Control and reports and escalates any adverse trends.
• Ensures existing methods comply with all required regulations and / or compendia. Propose and implement remediation plans to improve method robustness as needed.
• May be required to lead OOS / OOT investigations / deviations and to identify corrective actions to prevent recurrence.

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 Control 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.

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.

Strong knowledge of analytical methodologies such as flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin, and applying / interpretation of cGMP requirements.

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.

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 manufacturing projects to ensure company objectives. Up to 25% travel, domestic and international.

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 :

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.

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