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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Pay / Salary: $120,000 Salary
  • Location: Vista CA
  • Source: Business
  • Ad #: 15402
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Director of Quality — Vista, CA

Kelly Scientific Resources currently has a Direct Hire opportunity for a Director of Quality to oversee Quality Assurance, Quality Control, and Regulatory functions with a state-of-the art production facility in Vista, CA.

Responsibilities:

  • The Quality Director is responsible for the supervision and management of the Quality Assurance and Quality Control departments, including all Managers, Supervisors, Leads, Technicians, and Document Control Specialists.
  • Plan, coordinate, direct and supervise the activities of the Quality Assurance and Quality Control departments, also providing assistance on Regulatory matters as needed.
  • Manage site compliance, including but not limited to, city, state, and federal regulations and regulatory bodies.
  • Provide oversight and management of facility Quality Systems.
  • Direct and represent the company during all client and regulatory audits.
  • Prepare CAPA responses to inspection findings.
  • Conduct and coordinate internal, supplier, and contract manufacturer audits.
  • Review and approve Master Manufacturing Records.
  • Coordinate and/or conduct Annual Product Reviews.
  • Maintain relevant certifications, licenses, permits, and registrations.
  • Review and approve investigations and responses to complaints.
  • Continuously monitor and update senior management on developing quality and regulatory matters.
  • Work with cross-functional teams to identify quality trends and prepare periodic reports for review by senior management.
  • Performs other duties as assigned by VP of Quality and Regulatory.

Requirements:

  • Minimum Bachelor's degree in science or related discipline
  • 7-10 years of Quality management experience, preferably overseeing QA, QC, and Regulatory
  • ASQ Quality and/or CHA certification preferred
  • Experience with 21 CFR Parts 1 10, 111, ICH guidelines, OSHA, EPA and Labor regulations pertaining to job functions
  • Experience in the nutraceutical, pharmaceutical and/or medical device industry.
  • Experience in preparing, hosting, and responding to regulatory agencies and client audits
  • Proven experience conducting internal and external audits
  • Experience in problem solving and root cause analysis
  • Strong leadership and critical thinking skills

Apply Today! Questions? Call Justin at 714.971.0721 or email at justin.lynn@kellyscientific.com

 
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