Quality Manager

ILC Dover is a world leader in the innovative design and production of engineered products employing high-performance flexible materials. Since 1947, we have provided engineered solutions to complex customer problems. Initially known for the production of space suits for NASA, we leverage our vast materials, engineering, process, and design experience to create high performance systems for a wide range of industries. ILC Dover is a portfolio company of New Mountain Capital, which acquired the company in February 2020.

Recognized globally for our flexible containment solutions, ILC Dover serves customers in a diverse range of industries, including pharmaceutical and biopharmaceutical manufacturing, personal care, food and beverage, chemical, aerospace, healthcare and government agencies. ILC Dover’s visionary solutions improve efficiency, safeguard workers and product, and prevent disasters. For more information visit ILCDover.com and follow us on LinkedIn.

Job Summary:

In this role, you will partner, lead, and manage Quality for the Site. You will serve as a critical part of the site leadership quality organization with focus and responsibility in ensuring support to site operations for products manufactured, tested, and released for use in the biopharmaceutical industry occurs in a compliant manner.

The Plant Quality Manager leads cross-functional initiatives and teams to develop and improve organizational processes and both internal and external customer satisfaction. This position leads and develops direct reports and cross-functional team members where applicable. The Plant Quality Manager combines expertise in Continuous Improvement, quality management principles, tools and[HB1] techniques with high levels of business acumen to develop people, processes and associated metrics for the improvement of the business.

*Essential Job Duties:

• Ensures business, quality and compliance goals are met and in compliance to Global Quality policies and standards and relevant government issued quality and regulatory policies/ guidelines
• Ensures a comprehensive, robust, and effective Quality System is in place and implemented throughout the Site
• Manage Complaint Handling, CAPA, Training programs, Records, Quality System documents, Internal/External Audits and inspections.
• Utilizing strong data analytics, provide ongoing strategic review and continuous improvement[HB2] of the Quality initiatives utilizing robust project management methodologies.
• Collaborate with business partners to develop and implement innovative business solutions.
• Make decisions based on relevant data and current Good Manufacturing Practices (cGMPs)
• Approval or rejection of starting materials, intermediate, bulk, and finished products, ensuring that all vital testing is completed, and the associated records evaluated including approval of specifications, sampling instructions, test methods and other related Quality Control procedures
• Leads effective implementation, monitoring, and maintenance of site quality and systems, ensuring appropriate authorization of written procedures and documents, the monitoring, control and continuous improvement of the manufacturing environment, QC Lab areas, and warehousing environment[HB3] .
• Ensures qualification and maintenance of premises and equipment, and ensuring appropriate validations (e.g. equipment qualification and process validation) are done
• Ensures required initial and continuing training of personnel is carried out and adapted
• Responsible for leading site CAPA and management reviews[HB4] of process performance, product quality and of the Quality System and advocating continual improvement
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
• Development, Management and supervision of the Quality team by assisting in the development[HB5] of goals and key performance indicators, providing leadership for health authority inspections as well as regulatory awareness programs for each agency.
• Build and sustain employee engagement by crafting a Quality culture of right first time and efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Work as part of the global quality leadership team to drive quality best in class[HB6] .

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Manager

• Determined, enthusiastic and driven
• A true leader who has led transformational projects
• Strong management abilities to manage and develop staff
• Proven track record handling ambiguity, collaborating with, and influencing the most senior levels of the organization
• Multifaceted leadership with a balance between Quality and business mind-set

Qualifications:

• High School Degree, minimum, and 8+yrs in a Quality Organization supporting all facets of cGMP Activities (FDA's 6-system Approach) in the biological or pharmaceutical setting
• Bachelor of Engineering or Science Degree in a scientific discipline and 6+yrs in a Quality[HB7] Organization in the biological or pharmaceutical setting
• Knowledgeable of regulatory requirements (e.g. FDA/EMA/JP/ICH/PIC/S, etc.) applicable to biologics or pharmaceuticals. Ability to apply cGMP regulations and other international guidelines to all aspects of the position. Experience with regulatory inspections.
• Proven senior operational leadership qualities within a commercial manufacturing setting
• Proficient in 8D, SPC, Statistical capability, MSA.
• Six Sigma Green Belt / Black Belt (Preferred[HB8] )
• Proficient with word processing software; statistical analysis software (SPC); graphics software; order processing software, and database software
• Proficient with measurement, calibration, and test equipment (Preferred[HB9] )

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must regularly lift and /or move up to 10 pounds. Specific vision abilities required by this job include Close vision, Color vision, Distance vision and Depth perception. While performing the duties of this Job, the employee is regularly required to walk and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; stoop, kneel, crouch, or crawl and taste or smell.

As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran

PI174833064