JO-2641-Sr. Director – Quality
Lawrence, Kansas, United States
Experience: Director Management (Director/Head of Organization)
Education: Bachelor's Degree
Category: Quality Assurance / Safety
Industry: Healthcare / Pharmaceutical
Salary: Base of $225K - $250K per year + Annual Bonus Target of 30% + Sign-On Bonus – $15K
Reference ID: JO-2641
Date Posted: 04/21/2024
Shortcut: http://management-recruiters-of-edison.jobs.mrinetwork.com/KdUiCN
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 # 2641
Job Title: Sr. Director – Quality Location: Lawrence, KS
Compensation: Base of $225K - $250K per year + Annual Bonus Target of 30% + Sign-On Bonus – $15K
Relocation: YES - Client offers relo 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:
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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.
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Will periodically review the suitability and effectiveness of the quality system with executive management as well as manage regulatory inspections.
Job Description:
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Manage the batch review and release activities
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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
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Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirements
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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
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Interacts frequently with all levels of internal management as well as across functions and franchises
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Manages interactions with customers and regulators concerning the quality of products, systems, and processes
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Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
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Develops budget for plant or programs/department and ensures adherence to the budget
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Manages overall coaching, training, development, and succession plans for the team
Qualifications
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In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
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Strong leadership skills and demonstrated success in managing a team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
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Strong analytical, problem solving, and decision-making skills
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Excellent verbal and written communication skills
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Success working with multifunctional, global teams
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Excellent interpersonal/communication/influencing/negotiation skills required
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Extensive working knowledge of applicable quality and regulatory standards and regulations
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Experience in risk management, validation, analytics, and microbiology, within a GMP environment
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Quality expertise on tech transfer
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Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment
Candidate Must Have:
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Bachelors of Science or Engineering or related degree
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Min. 15 years of experience in Medical Device or Pharma Industry
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Min. 5 years of Quality Management experience in the Pharma Industry
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Excellent people, communication and management skills to create a team environment
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Good leadership skills to motivate plant personnel and gain their respect
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Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.
Candidate Nice to Have:
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Advanced degree or an MBA
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Experience with remediation of Quality systems in FDA 483 or Warning Letter environment
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Knowledge of Sterile Aseptic Filling Operations
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Startup or Small company experience working in a dynamic and hands-on role.
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Six Sigma, Lean Manufacturing, continuous improvement, etc.
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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,
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