Sr. Manager, Quality Assurance

Your mission

Sr. Manager, Quality Assurance

At Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.  We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre's foundation ownership enhances our ability to focus on creating long-term value for patients.   

Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.  

Pierre Fabre Pharmaceuticals is headquartered in Parsippany, NJ alongside Pierre Fabre USA Inc., a Pierre Fabre Laboratories subsidiary focused on dermatology and cosmetics.  

SUMMARY: 

Part of the Pierre Fabre Pharmaceuticals (PFP) Global Technical Operations team, the Sr. Manager Quality Assurance, Product Quality, is responsible for ensuring quality and compliance of process and product disposition and for identifying and driving continuous improvement as well as providing oversight of QC laboratory activities and personnel at the Denver location.  This role is instrumental in ensuring supply to patients by releasing material produced at PFP and CMO sites across both Clinical and Commercial and being an SME, and requires a deep understanding of regulatory guidelines set forth by regulatory agencies such as the FDA and EMA. The incumbent interacts cross-functionally across Technical Operations, Regulatory, Quality Control, and Process Sciences, to ensure on-time disposition is met.

ESSENTIAL FUNCTIONS:

• Responsible for administration of the Quality Management System as it applies to Quality Control operations and for supporting the release and distribution of clinical and commercial finished goods to global regions, ensuring compliance with Good Manufacturing Practices.
• Manages QC laboratory operations, ensuring accurate testing of raw materials, intermediates, and final products. Leads validation studies for analytical methods, stability testing, and release testing.
• Lead and mentor QA/QC team members, fostering a culture of quality excellence. Set performance goals, conduct evaluations, and provide ongoing feedback.
• Coordinate training programs to enhance team skills and keep personnel informed about regulatory updates.

• Monitor equipment calibration, maintenance, and troubleshooting to prevent deviations.
• Independently perform and manage batch release activities for production including, but not limited to, review of batch records, analytical data, certificates of analysis, and other documents.
• Develops, reviews, and continuously improves QA/QC policies, procedures, and guidelines. Ensure they align with regulatory requirements and cover all critical aspects of product quality.
• Provides quality oversight of cGMP activities supporting all material and product disposition including raw material & starting material receipt and disposition, Viral Vector, drug critical reagent, drug substance and drug product manufacturing, labeling, batch record review, and lot disposition.
• Provide quality documents to Regulatory Affairs and Clinical Operations to support Single Patient-Use (SPU) distribution.
• Serve as an SME in regulatory inspections, prepare for them, and respond to any observations or findings.
• Provides quality oversight and support for deviations, change controls, and CAPAs, as well as OOS, OOT, and Invalid Results investigations associated with QC and Product Quality.
• Establishes collaborative relationships with internal and external stakeholders to ensure timely documentation, resolution of quality issues, and implementation of effective CAPAs.
• Partners with cross-functional teams to ensure products are delivered on time and within specification.
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
• Review and approve any major/minor deviations, change proposals or other quality records, as needed, to support lot disposition and GMP investigations, within the relevant QMS requirements.
• Supports the Facilities team by providing review and approval of controlled documents (SOPs, WINS, etc.), completed Forms for new equipment, instrument change status, calibration assessment, work order requests, and environmental monitoring system alarm resolution.
• Perform review and approval of Quality documentation such as equipment, system, process, and method validations, qualification and validation reports, master batch records, validation master plans (VMPs), change control, risk assessments and technical reports.
• Review qualification/validation protocols and reports as well as Technical Transfer protocols and works within the Quality organization to interact with the Regulatory, Process Development, and Process Sciences Groups.
• Identify and support continuous improvement projects in collaboration with different cross functional teams to drive manufacturing reliability and enhance quality and efficiency.
• Acts as QC and Disposition Process SME.

REQUIRED EDUCATION AND EXPERIENCE:

• BS degree in life sciences or related field.
• 5+ years of experience in biopharmaceutical industry (prefer experiences in both large and small company environments), experience in batch disposition preferred.
• Experience in Aseptic Processing
• Strong knowledge of GMP, GLP, and relevant regulatory guidelines.
• Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight.
• Attention to detail with strong analytical and problem-solving skills
• Working knowledge of manufacturing and laboratory practices
• Excellent verbal and written communication skills; good interpersonal skills.

WORK ENVIRONMENT:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

LOCATION:

• Denver, CO
• Ability to travel up to 10% 

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. 

https://www.pierre-fabre.com/en-us 

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.