- 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.
- 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
- 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 skills to 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.
- 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
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Director of Quality - Lawrence, United States - MRINetwork Jobs
Description
Job Description
Job DescriptionOur 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 # 2636RJob Title: Director of Quality - Pharmaceutical
Location: Lawrence, KS
Compensation: Annual Salary of $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 at manufacturing 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:
Job Description:
Candidate Must Have:
Candidate Nice to Have:
Keywords: BioPharma, Pharma, Quality, ISO, FDA, QA, QC, CMO, Sterile Aseptic, filling, BFC, remediation
