Executive Director Commercial Quality Assurance

Location Redwood City
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Caroline Webster

Contact email: caroline.webster@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21505
Published: 21 days ago
Expiry date: 27 May 2021

Location: Redwood City, CA (potential to be remote)

Type: Full-time, permanent

The Company:

We have partnered with an innovative biotechnology company dedicated to delivering high-quality biosimilar therapeutics to expand patient access to life-changing medicines in regulated markets worldwide. Based in the San Francisco Bay area, this company is composed of a team of industry veterans with decades of experience in pioneering biologics companies. Our client leverages their collective expertise in key areas such as process science, analytical characterization, protein production and clinical-regulatory development to advance biosimilar development.

The role:

We are seeking a highly qualified Executive Director of Commercial Quality Assurance to lead the GMP QA function. Reporting to the Chief Quality Officer, the successful candidate will be responsible for establishing and operating the Quality Assurance Systems and Processes for the commercial manufacturing CMO network as well as the quality release of commercial products.

Responsibilities:

  • Lead, manage and oversee the Commercial Quality Assurance function in the execution of quality processes and procedures

  • Assure appropriate quality review of product, quality disposition of product, and overall regulatory compliance with cGMPs, BLA Holder Oversight Expectations, and the BLA

  • Ensure that commercial quality assurance systems and records are maintained in accordance with cGMP’s, FDA guidance, and other applicable global regulatory requirements

  • Execute quality processes and procedures in accordance with acceptable standards for quality of deliverables and decisions

  • Develop positive relationships with the quality and operations leaders at the drug substance, drug product, and finished product CMO’s as well as third party partners

  • Develop and maintain Quality Agreements, master batch records and production records

  • Assure completion of compliance audits and act a representative as needed during regulatory inspections

  • Establish and maintain cross-functional relationships with Operations, Technical and Manufacturing Oversight organization to ensure that Deviations, CAPA’s, and Changes are appropriately assessed and approved

  • Serve as delegate of the Head of Quality in Product Quality Review Boards and Change Review Boards

  • Responsible for Commercial Product Complaint investigation and closure (technical complaints) and for collaboration with the Drug Safety and Pharmacovigilance group on medical complaints

  • Responsible for compiling appropriate data and metrics for internal assessments including Quality Leadership Team, Quarterly Management Quality System Reviews and Product Quality Reviews

Required qualifications:

  • Bachelors’ degree in Engineering, Chemical or other life science related discipline

  • 15+ years' experience in Quality Assurance leadership roles in the biopharmaceutical industry

  • Experience operating quality systems and processes for product assessment and disposition within a commercial GMP environment for all aspects of manufacturing including Materials Control, Drug Substance, Drug Product, and Final Packaged Product

  • Demonstrated experience in managing and overseeing global CMOs and other external vendors

  • Subject matter expert in global cGMP expectations for biotechnology products and ICH Quality requirements

  • Experience creating and reviewing of production records as well as authoring and reviewing CMC regulatory submissions

  • Comfortable working in a fast paced and dynamic team environment

  • Solid judgment and decision-making skills

Salary: On application