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JO-2641-Sr. Director – Quality - Lawrence, United States - Management Recruiters of Edison
Description
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:
● 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
● 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 required
● 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
