THIS POSITION CAN BE LOCATED IN OUR HEADQUARTERS IN RADNOR, PA OR ANY AVANTOR MANUFACTURING FACILITY INCLUDING BETHLEHEM, PA BRIDGEWATER, NJ; PHILLIPSBURG, NJ OR PARIS, KY
The Director of Quality Systems leads the global Quality efforts of implementation, maintenance and improvement of the Quality Management System enterprise wide. Directs and supports QA efforts in all Avantor (Legacy VWR / Legacy Avantor) businesses and in the respective geographical area. This position shall promote a culture of Quality, compliance and continuous improvement throughout the organization via multiple channels. Makes decisions based on customer, associate, regulatory and company best interests. Drives strategic activities of Quality enterprise wide. Reports to the SVP Compliance.
Quality documentation services: develop, implement, communicate and maintain a quality plan to keep the Company’s Quality Systems and Policies into compliance with system requirements. Develops a global strategy for standardization of SOP’s and registrations, where applicable.
Certification management: ensure compliance with national and international standards.
Define and agree Quality procedures in conjunction with relevant operating staff.
Management of QMS compliance: set up and maintain controls for the Quality Management System – CAPA, Change Management, Change Notification, Non-Conformances, Recall, Documentation Control, Product Review, Record Retention.
Training Compliance / Quality Training: identify relevant Quality related training needs and facilitate delivery of training enterprise wide.
Supplier Qualification Program: implement and maintain an internal audit plan and perform internal audits/ external audits including Avantor group internal audits / cross border audits.
Liaise with customer auditors and ensure the execution of corrective action and compliance with customers’ needs.
Liaise with suppliers and ensure the execution of corrective action from audits / escalated complaints.
Oversee recall actions and feedback relevant Recall team.
Oversee responses to customer questionnaires, quality agreements and specifications.
Management Review Metrics / Analysis of Data of QMS: maintain, collate and analyses Quality performance data and charts against defined parameters.
Engage with sales and marketing leaders to convey current and future customer requirements.
Promote Quality achievement and performance improvement throughout the organization.
Systems Compliance Oversight.
Data Integrity Compliance.
Validation Oversight / Global System Execution.
Provide leadership and development opportunities for associates on the quality team. Make organizational decisions based on business needs and talent pool.
Lead communication efforts to inform Avantor associates, suppliers, and customers with regard Quality Alerts and complaints.
Oversight of the following leadership: Quality Systems and Analytical Services, Quality Management, Supplier Qualification, Validation, Quality Documentation, Change Notification, Data Integrity.
Support / oversight (where applicable) of the following: customer audits, supplier audits, FDA inspections, ISO surveillance/re-assessment audits, regulatory bodies within the QA areas and QA agreements,
Supplier QA agreements, supply chain quality standards, etc.
Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
Requires a bachelor's degree in biology, chemistry or related field. Master’s degree or higher preferred.
ASQ CQM – OE, ASQ CQA or equivalent, preferred.
Minimum of 15 years of quality management experience in a regulated industry such as, distribution, manufacturing, or supply chain industry.
8+ years of experience in managing others in regulated industry.
Experience in implementing quality system based on FDA and international standards.
Working knowledge of cGMP’s and regulations applicable to the FDA and comparable international regulatory agencies.
Experience in optimizing, qualifying, validating, transferring and troubleshooting analytical processes.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Working knowledge of: FDA regulations, ISO, IVD, EXCiPACT requirements amongst others
Strong interpersonal skills with the ability to engage others and gain their buy-in on issues or in situations where there is no direct line of authority
Excellent leadership, decision-making and analytical skills
Strong people management skills and ability to assess performance of direct reports
Strong business acumen
Ability to prioritize the department’s work and ensure deadlines are met
Participation in industry relevant affiliations, such as RX360, IPEC, etc., preferred.
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Up to 30% domestic and international travel.
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.
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.
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.
Avantor companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Avantor® is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.