Director of Quality - Pharmaceutical

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 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, QC and 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 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.

Candidate Nice to Have:

• Advanced degree or an MBA
• Experience with remediation of Quality 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