Director Of Quality - Pharmaceutica

Our client – a growing company with multiple plants in the US, needs a Director of Quality at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $190K Annual Bonus Relocation assistance Full Benefit Package.

Job Posting 2647R Job Title: Director of Quality

• Pharmaceutical Location: Lawrence, KS Compensation:Annual Salaryof $150K - $190K Annual Bonus Target – 20% Relocation:
  
  YES - Client offers relocation assistance and payments for expenses Benefits: Full package for medical, dental insurance, 401K, etc. This is a privately held company in business for 40 years with 300 people atmanufacturing sites in CA, KS Group Info:
  
  Be part of the medical device and pharmaceutical contract manufacturing site with around 100 employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing. The new operation expansion is for Pharma

• Blow Fill Cap – BFC of Sterile Solutions. This Quality group has around 25 people from Quality Control, Quality Assurance, Validation, Compliance.
  
  This role will report to the Sr. Director of Quality. The 3 Managers from QA, QCand Quality with total of 20 people will report to this person.
  
  Job Summary: The Quality Director develops and deploys the quality system for a small to mid-size plant manufacturing Medical Devices and Pharma Solutions, while assuring systems and procedures for regulatory compliance are established and deployed. Will periodically review the suitability and effectiveness of the quality system with executive management as well as manage regulatory inspections.
  
  Job Description: Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and company policies Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirements Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements Interacts frequently with all levels of internal management as well as across functions and franchises Manages interactions with customers and regulators concerning the quality of products, systems, and processes Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility Candidate Must Have:
  
  Bachelors of Science in Chemistry, Microbiology, Engineering or related degree Min. 10 years of experience in Medical Device or Pharma Industry Min. 5 years of Quality Management experience in the Pharmaceutical Industry Excellent people, communication and management skillsto create a team environment In-depth knowledge of the FDA regulatory environment for manufacture of pharmaceuticals, medical devices, and therapeutics. In-depth knowledge of Production Quality, Change Management, Supplier Quality, Non-Conformance investigations, Complaint management, and Document Control. Experience in risk management, tech transfer, validation, analytics, and microbiology and/or chemistry, within a GMP environment.
  
  Good leadership skills to motivate plant personnel and gain their respect Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc. Candidate Nice to Have: Advanced degree or an MBA Experience with remediation ofQuality systems in FDA 483 or warning letter situation Knowledge of Sterile Aseptic Filling Operations Startup or Small company experience working in a dynamic and hands-on role.
  
  Six Sigma, Lean Manufacturing, continuous improvement, etc. Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment Contract Manufacturing experience working closely with customers and clients Keywords:BioPharma, Pharma, Quality, ISO, FDA, QA, QC, CMO, Sterile Aseptic, filling, BFC, remediation