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PrincePerelson & Associates Senior Quality Manager in Salt Lake City, Utah

Senior Quality Manager

Salt Lake City, UT

The Senior Quality Manager joins a progressive, biologics drug company led by a team of highly reputable Doctors, medical professionals and leaders in this space. The position reports directly to COO and will oversee all cGMP quality management systems, quality inspections of raw materials and final product release. A true people leader who is willing to take on new challenges in a high growth environment. A person capable of scaling, wearing multiple hats and contribute at the ground level. Candidate must have experience building a cGMP quality system and supporting IND work. This person will also own risk assessment. 6+years of Quality and lab experience with a biomedical, pharma or biologics company. Position based out of Salt Lake City, Utah.

Exposure/Activities of Senior Quality Manager:

  • Develop, define and oversee the cGMP quality management system

  • Oversee the quality inspections of raw materials and final product release

  • Alongside COO, lead all internal and external audits

  • Oversee and lead all key quality processes including CAPA

  • Perform production work with the quality team on the production line

  • Lead, mentor and develop a core group of quality technicians

  • Ensures clarity among objectives, responsibility and timelines

  • Works alongside COO to support the commercialization of a product

  • Contributes to the overall company strategy, playing an active role on leadership team

Skills & Abilities of Senior Quality Manager:

  • Exceptional verbal, presentation and written communication skills

  • Interact with colleagues, direct reports, Board of Directors and Leadership team

  • Ability to communicate ones position clearly

  • Proven experience managing and leading quality teams

  • Operate with a healthy sense of urgency

  • Deploy lean development practices

  • Appreciate the uncertainty and excitement surrounding a start-up

  • Drive through results

  • Flexible work style is required to meet deadlines

Qualifications of Senior Quality Manager:

  • Bachelor’s degree in scientific field, post-graduate work preferred

  • 5+ years of experience in a Quality leadership role

  • 5+ years of experience in cGMP biologic production environment preferred

  • Lab and Clean room experience required

  • Six- Sigma experience preferred

  • Proficient in MS Office Suite i

  • Self-starter, humble, passionate, integrity-centered, entrepreneurial and respectful

Benefits for Senior Quality Manager:

  • 100% paid Medical benefits

  • 100% paid Dental benefits

  • 100% paid Vision benefits

  • STD, LTD, Group Life Insurance

  • 401K matching and stock options

  • PTO, Sick, Paid Holidays

PrincePerelson & Associates is an Equal Opportunity Employer and we do not discriminate against applicants due to race, color, religion, sex, national origin, age, disability, genetics, veteran status, or on the basis of disability or any other federal, state or local protected class. All applicants applying for U.S. job openings must be authorized to work in the United States.