Our client – a growing company with multiple plants in the US, needs a Sr.Director of Quality at their plant expanding to manufacture pharmaceutical products. Excellent salary up to $250K Annual Bonus Sign on Bonus Relocation Assistance Full Benefit Package 4 Weeks’ vacation.
Job Posting # 2648R
Job Title: Sr. Director of Quality Location: Lawrence, KS
Compensation:Base of $225K - $250K per year Annual Bonus Target of 30% Sign-On Bonus – $15K
Relocation: YES - Client offers relocation assistance with a lump Sum sign on Bonus
Benefits: Full package for medical, dental insurance, 401K 4 Weeks’ Vacation 13 days - PTO, etc.
Our client is a privately held company in business for 40 years with manufacturing sites in CA KS with around 300 people
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 and this position reports to the Plant – General Manager.
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
QualificationsIn 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
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent Interpersonal/communication/influencing/negotiation Skills RequiredExtensive 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. 15 years of experience in Medical Device or Pharma Industry
Min. 5 years of Quality Management experience in the Pharma 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 in FDA 483 or Warning Letter environment
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, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS,Management, Validation, CDMO, Manufacturing, Plant,