- 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.
- 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
- 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
- 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.
- 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
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Sr. Director of Quality - Lawrence, United States - MRINetwork Jobs
Description
Job Description
Job DescriptionOur 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 # 2648RJob 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:
Job Description:
Qualifications
Candidate Must Have:
Candidate Nice to Have:
Keywords: BioPharma, Pharma, Quality, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS, Management, Validation, CDMO, Manufacturing, Plant,
