Sr. Director of Quality - Pharmaceutical

Lawrence, Kansas, United States


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Type: Permanent

Experience: Director Management (Director/Head of Organization)

Education: Bachelor's Degree

Category: Quality Assurance / Safety

Industry: Healthcare / Pharmaceutical

Company: Management Recruiters of Edison

Salary: $200K - $250K per year + Annual Bonus + Relocation assistance

Reference ID: w56tbU

Date Posted: 08/05/2022

Shortcut: http://jobs.mrinetwork.com/9dLuKi


Our client – a global company with multiple plants in the US, needs a Sr. Director of Quality at a growing plant expanding to manufacture pharmaceutical products. Excellent salary up to $250K + Annual Bonus + Sign on Bonus for Relocation + Full Benefit Package.

Job Posting # 2510R

Job Title: Sr. Director of Quality - Pharmaceutical                                  

Location:  Lawrence, KS                            

 

Compensation: Base salary of $200K - $250K per year + Annual Performance Bonus

 

Relocation:  YES - Client offers relo assistance with a lump Sum sign on Bonus

 

Benefits:  Full package for medical, dental insurance, 401K, Profit Sharing, etc.

 

Our client is a privately held group of global companies in business for 40 years with 1,400 people and manufacturing sites in CA, TX, KY and 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 Fill Finish Seal – FFS of Sterile Aseptic liquids.

 

This Quality group has around 25 people from Quality control, Quality Assurance, Validation, Compliance. This role will be a peer position of the General - Plant Manager and also report to the Executive VP.

 

Job Summary:

  • The Senior Quality Director develops and deploys the quality system for a small to mid-size plant manufacturing Medical Devices and Pharma Biologics, 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:

  • Manage the batch review and release activities
  • 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
  • Develops budget for plant or programs/department and ensures adherence to the budget
  • Manages overall coaching, training, development, and succession plans for the team

Qualifications

  • In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
  • Strong leadership skills and demonstrated success in managing a team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
  • Success working with multifunctional, global teams
  • Extensive working knowledge of applicable quality and regulatory standards and regulations
  • Experience in risk management, validation, analytics, and microbiology, within a GMP environment
  • Quality expertise on tech transfer
  • Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Candidate Must Have:

  • Bachelors of Science or 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
  • 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
  • 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.
  • Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, ISO, FDA, 483, Consent Decree, QA, QC, CMO, Sterile Aseptic, filling, FFS,

 

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