The Director, Quality Systems Management is the global leader of the functions creating and owning policies, processes, and procedures for all subsystems (e.g. CAPA, Manufacturing Controls, Design and Development Control, Risk Management, Document Control, etc.) of the Quality Management System. The Director, Quality Systems Management is responsible for setting Avantors Quality System strategy for all aspects of the business. In addition, the Director is responsible for the creation and ownership of all Quality System policies, processes, and procedures, and for sustaining a center of excellence compliant to regulations, standards, and guidelines governing Quality System activities for medical device, pharmaceutical, and biological products.
Ensure Quality System activities are compliant with governing regulations (e.g. Code of Federal Regulations CFR, Medical Device Directive MDD, etc.), standards (e.g. International Organization for Standardization ISO), and guidelines (e.g. International Conference on Harmonization ICH).
Serve as subject matter expert for Quality System processes.
Harmonize Quality System activities across all regions of the globe for all Avantor businesses.
Analyze and monitor costs associated with Quality System activities.
Establish annual budgets and quarterly forecasts. Make necessary changes to assure annual budgets are met, and/or reforecast in accordance with management and finance approvals.
Respond to verbal and written requests from regulatory agencies and internal/external customers, as needed.
Handle escalated conversations with patients and/or customers avoid litigious or compromising issues, provide information, educate and assure the patient and/or customer regarding the quality of Avantors Quality System.
Resolve customer concerns with potentially litigious issues.
Provide generalized company, departmental and product knowledge as required.
Monitor department processes and workflow for opportunities for improvement and optimization.
Drive Operational Excellence programs across the department and across the Avantor network.
Monitor changes in regulations, standards, and guidance, and provide recommendations, and implementation plans for adherence to new or changing requirements.
Ensure timely integration of Quality System policies, processes, and procedures for acquired or newly launched products.
Ensure that all team members receive appropriate and timely training.
Communicate across all applicable Avantor businesses to ensure Quality System metrics are clearly visible and operations are maintained within a state of control.
Direct management and teams to continually evaluate current policies, procedures and practices to develop and implement improvements.
Represent the Quality Management System during internal/external audits and inspections. Serves as company representative to various US and international regulatory bodies (regulatory authorities and notified bodies). Interacts directly with designated points of contact.
Monitor work flow to ensure quantity and quality are consistently met. Continually initiate plans to maximize use of resources, and/or take corrective action to resolve problems to accomplish department tasks and goals.
Conduct management activities such as interviewing/hiring new employees, processing time records and PTO requests, producing and administering performance evaluations, and any employee disciplinary actions.
Assess and define department training needs. Confirm all training needs are met, and training is completed within the expected timeframes.
EDUCATION AND EXPERIENCE
Bachelors degree or equivalent in a Life Science, Engineering, or Physical Sciences area of study.
Advanced degree is strongly desired.
Certification (e.g. CQE, CQA, CRE, etc.) by a recognized certifying body (e.g. ASQ) is strongly desired.
Experience of 15 or more years of increasing responsibility for Quality, Engineering, Medical Safety, or Compliance functions with at least 7 years in a managerial capacity.
Previous experience in managing a Quality System or multiple sub-processes of a Quality System.
SKILLS AND ABILITIES
Knowledge of regulations (e.g. Code of Federal Regulations CFR, Medical Device Directive MDD, etc.), standards (e.g. International Organization for Standardization ISO), and guidelines (e.g. International Conference on Harmonization ICH), governing the manufacture and control of medical device, pharmaceutical, chemical, and/or biological products.
Strong technical knowledge of supported medical device, pharmaceutical, and/or biological products desired.
Excellent written, verbal, listening, communication and team building skills.
Demonstrated ability to work effectively with, and lead, cross-functional teams.
Ability to effectively prioritize and manage multiple project workloads.
Experience with trending and analysis reporting.
Demonstrated ability to manage and lead people.
Knowledge of adverse event reporting, complaint handling, and field corrective action processes.
Strong leadership ability.
Ability to influence without authority.
Excellent critical thinking and problem-solving ability.
Effective communication and collaboration skills.
Ability to review, analyze, summarize, and interpret data draw conclusions and make recommendations and decisions, write reports, and give oral presentations tailored to the receiving audience.
Sense of urgency and intellectual curiosity.
Demonstrated continuous improvement philosophy.
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.