Senior Quality Assurance Operations Manager

Location
Brisbane, California, United States
Posted
Nov 03, 2020
Ref
1241386096
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference.

If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

The successful candidate should be able to perform the following QA Operations responsibilities and activities. This includes but is not limited to:
  • Develop quality oversight strategy for selected contract manufacturing organizations.
  • Act as Quality lead for program in GMP manufacturing.
  • Perform QA GMP vendor audits and write audit reports with findings, when necessary.
  • Advise, review and approve master batch records and executed batch records.
  • Responsible for lot disposition for selected contract manufacturing organizations by performing review and approval of QA certificate of release of product and approval of validation master plans (VMPs), process validation protocols and reports.
  • Review and approval of analytical methods, product specifications, analytical method validation protocols and reports.
  • Review and approval of stability protocols, data tables and stability reports.
  • Develop, advise, review and approve Quality Systems documents (procedures, specifications, protocols, deviations, CAPAs, etc.),
  • Manage, review and approve change controls (CC) and CC packages for closure.
  • Investigate, manage and approve product complaints reports for closure.
  • Assist with product recall / stock recovery investigations and reports, as necessary,
  • Assist with administration of the Quality Systems, as necessary.
  • Partner with Manufacturing, Formulation Development, Technical Operations, Analytical Chemistry, and Quality Control to ensure products are delivered on time and within specification.
  • Work collaboratively with cross-functional project teams.
  • Serve as MyoKardia's quality liaison with contracted manufacturing organizations (GMP manufacturing, QC testing and/or other vendors), as necessary.
  • Presenting as subject matter expert (SME) during regulatory inspections.
  • Stay abreast of changes in applicable FDA and European regulations, directives and guidelines and determine potential impact on company GMP activities.
  • Must be capable and willing to travel (up to 25%), including international travel.
  • Maintain flexibility to perform other / additional tasks as assigned.
Education:
  • BS/BA degree in a scientific field required; advanced degree is a plus
  • ASQ certification a plus
Experience:
  • Typically requires a minimum of 10+ years in biotech/pharmaceutical industry, with 8+ years of Quality Assurance experience
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
  • Excellent oral and written communications skills
  • Excellent organizational skills, with ability to successfully manage multiple priorities
  • Strong influencing skills: proven ability to get things done
  • Ability to work effectively with cross-functional teams
  • Late stage drug development, Regulatory (NDA) submission and commercial manufacturing experience.
  • Experience with inspection readiness process and able to provide recommendations for its continuous improvement