- The Senior Quality Director will be responsible for developing and implementing quality systems at a plant focused on manufacturing Medical Devices and Pharma Biologics, ensuring compliance with regulations and implementing effective procedures.
- Regularly reviewing the quality system's performance with executive management, overseeing regulatory inspections, and driving continuous improvement initiatives.
- Oversee batch review and release activities.
- Lead large programs and departments to support company-wide initiatives, ensuring product quality and compliance with regulations and policies.
- Develop and implement quality systems to guarantee products meet defined requirements.
- Drive local process and system improvements, aligning with corporate objectives for enhanced quality, reliability, and cost-effectiveness.
- Interact across all management levels, functions, franchises, and engage with customers and regulators on product quality matters.
- Ensure compliance with established specifications and procedures to maintain product quality standards.
- Develop budgets and monitor adherence.
- Provide coaching, training, and development opportunities for the team.
- Detailed knowledge of the regulatory landscape in medical device and therapeutics manufacturing.
- Proven leadership skills, adept at managing teams in a matrix environment, and global collaboration.
- Strong analytical, problem-solving, and decision-making capabilities.
- Excellent verbal and written communication skills.
- Experience with global, multifunctional teams.
- Strong interpersonal, negotiation, and influencing skills.
- Thorough understanding of quality and regulatory standards and regulations.
- Expertise in risk management, validation, analytics, microbiology in a GMP setting.
- Quality proficiency in tech transfer.
- Ability to adapt to an ISO 7/ISO 8 manufacturing environment.
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Sr. Director of Quality - Lawrence, United States - Management Recruiters of Edison
Description
Our client is a progressive company with various manufacturing plants in the US currently looking for a skilled Senior Director of Quality to join their team at a plant dedicated to producing pharmaceutical products. The position offers a competitive salary of up to $250K along with additional perks like an Annual Bonus, Sign-On Bonus, Relocation Assistance, a comprehensive Benefit Package, and 4 Weeks of vacation.
Job Title: Senior Director of Quality
Location: Lawrence, KS
Compensation: Base salary ranging from $225K - $250K per year, Annual Bonus 30% target, Sign-On Bonus of $15K
Relocation: YES - Including a lump sum Sign-On Bonus
Benefits: Comprehensive package including medical and dental insurance, 401K, 4 Weeks of vacation, 13 days of PTO, and more.
With over 40 years of experience, our client is a well-established company with manufacturing sites in CA and KS, employing approximately 300 individuals.
Group Info: Join a dynamic team within the medical device and pharmaceutical contract manufacturing division consisting of over 100 employees, expected to grow due to a significant expansion in pharmaceutical manufacturing.
The company is currently expanding operations to include Pharma Fill Finish Seal (FFS) of Sterile Aseptic liquids. The Quality group, comprising about 25 professionals from various departments, reports to the Plant General Manager.
Job Summary:
Job Description:
Qualifications:
