The Director Manufacturing Quality Assurance, Americas is responsible for strategic oversight of all Quality Assurance Activities, as defined by VWR Manufacturing and Distribution Quality Management Systems, applicable FDA and EU regulations, ISO and EXCiPACT requirements and Management. Works directly with the Americas QA Directors, Managers and site Quality Assurance professionals to provide guidance and support. Works directly with Americas Validation professionals to provide guidance and support. Oversees VWR s Global Quality Management System and technical professionals to provide guidance and support. Support Vice President of Quality Assurance in related tasks and interacts with leadership when required to advise necessary continuous improvement efforts so that systems and processes are in line with overall company strategy and quality policy. Strategically and tactically provides technical input and advises / implements necessary process and documentation changes. Makes decisions based on customer, associate and company best interests. Assures strategic and tactical activities of Quality Assurance across manufacturing and distribution sites for the Americas.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
Ownership of VWR s quality processes and development of strategic quality, vision, mission, goals, and objectives for the VWR Manufacturing for the Americas in conjunction with VWR s strategic plan.
Attend to and guide critical inspections as required.
Oversee the development and application of VWR s Americas Global Quality Management Systems. Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms. Harmonize, where possible, across manufacturing and distribution sites.Have working knowledge of and support compliance to support all of the regulatory and standard requirements as related to the products produced by the VWR Manufacturing sites within the Americas which include but are not limited to ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR) Part 11, 21 CFR 820 & 210/211, European Medical Device Directives and EXCiPACT. Direct and support FDA, EXCiPACT, and ISO registration and implementation. Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes. Provide enterprise-wide strategic insight to Global VP QA and Senior Leadership when necessary.Maintain the integration of all regulatory and standard requirements as related to the products produced by the VWR Manufacturing sites within the Americas which include but are not limited to FDA and EU regulations and ISO and EXCiPACT standards into the Quality Management Systems (QMS). Support and advise necessary continuous improvement projects as a result of periodic trend reporting; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality event. Use Six Sigma and Lean Manufacturing methodology to drive quality system improvements. Create, implement, and maintain QA KPIs for NA QA scorecard process, process improvements, key initiatives, projects, and tasks, as assigned.Attend site Management Review Meetings if/when necessary.
Ownership of VWR s Global Quality Management System and associated team. Develop roadmap for VWR site integration and management of priorities. Leads global governance team.
Ownership of VWR s Validation Global Strategy and associated team. Develops roadmap for VWR compliance with validation requirements and management of priorities. Leads global governance team.
Develop and effectively manage key relationships with business partners, in particular Operations and Commercial leaders. Benchmark and network within Humanscale and outside the company to develop new ideas that enhance the quality function and performance, and drive these to execution.
Act as customer quality liaison
Onboard new VWR manufacturing acquisitions and support the integration of these facilities within the VWR quality organization.
Provide training as requested. Prepare, conduct, and advise necessary training on quality assurance concepts and tools.
Act as customer quality liaison for critical customer audits and quality agreements when necessary.
Direct Supplier Quality program at Americas level, ensuring appropriate processes and resources are in place for initial evaluation and on-site audits and synergies across manufacturing and distribution.
Create and Direct Manufacturing Americas change notification services in alignment with Global QA.
Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
Bachelor's degree in Engineering, Life Sciences or related discipline
10+ years applicable experience
5+ years leadership experience
The following certifications are strongly preferred: American Society of Quality (ASQ) certifications as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE)
Six Sigma training
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Strong interpersonal and people management skills
Ability to think strategically and interact with all levels of the organization
Functional knowledge of Microsoft Outlook, Word, and Excel, (or equivalent), highly desired. Previous exposure and experience with automated inventory control systems strongly recommended.
Demonstrated knowledge and experience with software systems and integration with the quality system.
Excellent communication skills verbal and written
Strong understanding of ISO 9001, 14385, 13485 and 17025 standards.
Significant project management experience
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Up to 30% travel.
Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at ...@avantorinc.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.