Quality Assurance Supervisor

Location Boston
Discipline: Quality Assurance
Job type: Permanent
Contact name: Caroline Webster

Contact email: caroline.webster@rbwconsulting.com
Contact phone: +1 617 982 1238
Published: 19 days ago
Expiry date: 04 November 2021

The Company:

We have partnered with a well-established global biotech sponsor company, dedicated to the development of a highly innovative new class of biotherapeutics. Our client's cutting-edge scientific platform has massive potential to treat a range of diseases from cancer, to infectious disease and cardiovascular disease. This is a once in a lifetime opportunity to join a company that is boldly paving the path forward to develop a vaccine in the global fight against COVID-19. Join an innovative global team dedicated to improving the lives of patients through developing treatments for infectious diseases like COVID-19, cancer, rare and cardiovascular disease.

The successful Quality Assurance Supervisor candidate will be part of a cohesive team responsible for supporting cGMP drug products produced internally.  They will provide real time quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical and commercial products.  Strong decision-making skills and independent thinking will be paramount for candidate success. They will interact fluidly with peers and management in Manufacturing, and cross-functionally with Quality Control, Logistical and Process Development Technology Transfer counterparts.   

 Responsibilities:

  •  Manage a team of QA associates and specialists responsible for providing on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues.

  • Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed

  • Coordinate training, professional development and growth of the QA on the floor team

  • Lead routine walkthroughs of the manufacturing suites, QC labs, and Warehouse, partnering with support teams

  • Oversee process operations to ensure compliance with procedures and cGMP specifications.

  • Demonstrate knowledge of standard manufacturing compliance, quality disposition, quality system review. Support quality functional groups on as needed basis.

  • Communicate risks and compliance gaps for quality and GMP process/systems

  • Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.

  • Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.

  • Author and review SOPs and policies to ensure compliance and adherence to regulations/cGMP operations.

  • Support manufacturing teams to initiate and triage new deviation events, reviews minor and major manufacturing deviations

  • Oversee and perform review of executed electronic and paper batch record documentation.

  • Collaborate cross functionally to support disposition of Plasmid, Drug Substance and Drug Product

  • Ensure safe work habits by ensuring  adhere to safety procedures and guidelines.

  • Utilize subject matter knowledge to improve operational efficiency. 

Basic Qualifications:

  • 6-8 years’ experience in a GMP manufacturing environment

  • Bachelor’s degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field

  • Extensive knowledge and understanding of cGMPs and FDA guidelines for biopharmaceutical drug development required

  • Excellent verbal and written communication skills

  • Experience providing QA support and oversight to manufacturing operations

  • Minimum of 1 year leading teams is preferred

 Our client is a smoke-free, alcohol-free and drug-free work environment, committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law and will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. NOTE: our client requires all US based employees to be fully vaccinated against COVID-19.