Sr. Supervisor, QA Operations

Senior Supervisor, QA Operations

Bothell, Washington

 

**This is a Wed-Sat AM Shift (6am-4:30pm)

 

The QA Sr. Supervisor is responsible for leading a team that provides QA oversight of GMP operations including batch record review production and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards.

 

In addition, the Supervisor will be responsible for the people involved in the day to day Quality Assurance Operations associated with the production of both clinical and commercial autologous cell therapy product. This person will be a key leader responsible for GMP operations and meeting critical business goals.

 

Who You Are:

 

  • Master’s degree in a related field is preferred. Bachelor’s degree is required.
  • 7+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
  • Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.
  • Proven commitment to quality and continuous improvement.
  • Possesses excellent compliance understanding. This includes both technical and regulatory requirements pertaining to equipment function and application.

 

What You'll Do:

 

  • Using the production schedule, develops and manages a daily plan for a work team of Quality Assurance Operations associates.
  • Leads/supports deviation process, investigations and closure. Participates in cross functional project teams, provides QA support to technical transfers in conjunction with relevant teams/ individuals.
  • Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
  • Ensures QA reviews and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols and reports.
  • Interviews, hires, coaches, motivates, and develops exceptional staff. Sets performance objectives and development plans. Monitors performance progress conducts annual performance reviews for all direct reports and recommends advancements for Quality Assurance Operations Team when appropriate.
  • Assists in the design, implementation and continuous improvement of Quality Assurance systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.