-
Facility Management Director
1 week ago
FusionWorks Lawrence, United StatesAre you passionate about helping people in your nursing profession and value finding joy in your work? · ▸ If a respectful work environment is important to you · ▸ If you are looking for a strong team and a positive work atmosphere · ▸ If appreciation and recognition motivate you ...
-
Executive Director
2 weeks ago
InsideHigherEd Lawrence, United States Executive Administration Jobs ,· University of Kansas · Executive Director of the Achievement and Assessment Institute · Lawrence, KS · WittKieffer is proud to partner with the University of Kansas (KU) as they search for an entrepreneurial, forward-thinking operational and strategic leader to serve as the in ...
-
Director of Programs
1 week ago
Goodfaith Lawrence, United StatesPosition: Director of Programs · Reports to: Senior Director of Strategy and Implementation · FLSA Status: Full-time, exempt, salaried position · Application: To be considered, send cover letter and resume to Joe Dignam, · Mission and Background · Goodfaith is an independent C ...
-
Executive Director
2 weeks ago
University of Kansas Lawrence, United States Full timeDetails Posted: 26-Apr-24 · Location: Lawrence, Kansas · Type: Full Time · Categories: · Executive Director/CEO Internal Number: · University of Kansas · Executive Director of the Achievement and Assessment Institute · Lawrence, KS WittKieffer is proud to partner with (KU) ...
-
Director of Ceremonies/Events
4 weeks ago
InsideHigherEd Lawrence, United StatesPosition OverviewThe Director of University Ceremonies and Special Events is the university's lead event planner for signature university events that garner widespread attention and elevate the university's brand. Additionally, the Director helps guide and shape processes and pol ...
-
Associate Director of Graduate
4 weeks ago
InsideHigherEd Lawrence, United StatesPosition OverviewAt KU Enrollment Marketing and Communications, we reach prospective students of every kind from around the world and tell the story of how the University of Kansas inspires Jayhawks to reach their full potential, fuels discovery and ambition, and sets them for a ...
-
Director of Housing Facilities
1 week ago
InsideHigherEd Lawrence, United StatesPosition OverviewReporting to the Executive Director of Housing & Residence Life, the Director of Housing Facilities manages the maintenance and operations of facilities under the control of Housing & Residence Life at the University of Kansas, a $45 million auxiliary with over 2 ...
-
Associate Director of Undergraduate
4 weeks ago
InsideHigherEd Lawrence, United StatesPosition OverviewAt KU Enrollment Marketing and Communications, we reach prospective students of every kind from around the world and tell the story of how the University of Kansas inspires Jayhawks to reach their full potential, fuels discovery and ambition, and sets them for a ...
-
Sr. Director of Engineering
3 weeks ago
Management Recruiters of Edison Lawrence, United StatesOur client – a global company with multiple plants in the US, needs a Sr. Director of Plant Engineering & Maintenance at a growing plant expanding to manufacture pharmaceutical products. Excellent salary up to $225K + Annual Bonus + Sign on Bonus + Relocation Assistance + Full B ...
-
Center Director
5 hours ago
Sylvan Lawrence, United StatesGENERAL SUMMARY · The Director is responsible for delivering a high quality personal customer experience by ensuring that Sylvan education programs are delivered by teachers as designed and that the ongoing education needs of Sylvan families are met. The Director is responsible ...
-
Director of Quality
5 days ago
Management Recruiters of Edison Lawrence, United States PermanentOur client – a growing company with multiple plants in the US, needs a Director of Quality at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $190K + Annual Bonus + Relocation assistance + Full Benefit Package. · Job Posting # 2647 ...
-
Center Director
5 hours ago
Sylvan Learning Lawrence, United StatesGENERAL SUMMARY · The Director is responsible for delivering a high-quality personal customer experience by ensuring that Sylvan education programs are delivered by teachers as designed and that the ongoing education needs of Sylvan families are met. The Director is responsible f ...
-
Director, Business Development
5 days ago
Nationwide Private Client Lawrence, United States Full timeIf you're passionate about helping people protect what matters most to them, as well as innovating and simplifying processes and operations to provide the best customer value, then Nationwide's Property and Casualty team could be the place for you At Nationwide, "on your side" go ...
-
Director of Quality
3 weeks ago
MRINetwork Jobs Lawrence, United StatesJob Description · Job DescriptionOur client – a growing company with multiple plants in the US, needs a Director of Quality at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $190K + Annual Bonus + Relocation assistance + Full Benefit Packa ...
-
Director of Finance
5 hours ago
UNIVERSITY OF KANSAS MEMORIAL Lawrence, United StatesJob Details · Job Location · Lawrence, KS · Description · As the Director of Finance for a $32 million organization, the incumbent leads financial process optimization and compliance efforts, implementing innovative technologies and providing strategic analysis to drive inform ...
-
Center Director
2 weeks ago
Sylvan Learning, Inc. Lawrence, United StatesThe Director is responsible for delivering a high quality personal customer experience by ensuring that Sylvan education programs are delivered by teachers as designed and that the ongoing education needs of Sylvan families are met. The Director is r Director, Customer Experience ...
-
Director of Quality
3 weeks ago
MRINetwork Jobs Lawrence, United StatesJob Description · Job DescriptionOur client – a growing company with multiple plants in the US, needs a Director of Quality at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $190K + Annual Bonus + Relocation assistance + Full Benefit Packa ...
-
Director of Quality
1 week ago
Management Recruiters of Edison San Francisco, United States PermanentOur client - a growing company with multiple plants in the US, needs a Director of Quality at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $190K + Annual Bonus + Relocation assistance + Full Benefit Package. Job Posting # 2647R Job Title ...
-
Director of Quality
2 days ago
Management Recruiters of Edison Lawrence, United StatesOur client – a growing company with multiple plants in the US, needs a Director of Quality at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $190K + Annual Bonus + Relocation assistance + Full Benefit Package. · Please ensure you read the ...
-
Director of Sorority and Fraternity Life
2 weeks ago
InsideHigherEd Lawrence, United States Administrative Jobs ,Position OverviewEstablished in 1865, the University of Kansas (KU) is a prominent public research and teaching institution. With over 29,000 students and more than 2,000 faculty members spread across five campuses—Lawrence, Kansas City, Overland Park, Wichita, and Salina—KU stan ...
Sr. Director - Lawrence, KS, 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 # 2641Job 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.
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
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,
