Our client, a well-known growing CDMO is seeking a Director of Quality and Regulatory Affairs. The Director of Quality is responsible for the development, alignment and implementation of the Quality Management Systems, Regulatory and Complaint Management strategies. This position also provides insight into solutions and direction on general business matters as it is related to the Quality Department. This position is responsible for directing and leading the company’s policies involving government compliance as well as national regulations.
Essential Functions
- Assume a leadership role with authority for the development, implementation, evaluation, and maintenance of a comprehensive and effective Quality Systems program that complies with FDA regulations, ISO requirements, and other applicable regulatory bodies such as Maryland State bodies and standards as well as corporate documents and requirements.
- Responsible for managing the QA, QC and QC laboratories and staff. Including proper execution of stability projects.
- Report to the Leadership Team at Management Review meetings on the performance and status of the quality system.
- Assist in development of corporate metrics.
- Act as a liaison for the company during routine and non-routine inspections of the facility by the FDA, ISO, or other regulatory groups and/or customers. Respond with appropriate CAPA plans to all audits conducted.
- Maintain all required registrations timely.
- Support development and execution of equipment qualifications and process validations with manufacturing and engineering.
- Work closely with Sales and Product Management to support and drive new product and project development activities.
- Develop and deliver presentations to clients as needed.
- Provide regulatory guidance on all new projects.
- Ensure timely execution of quality and regulatory action items.
- Manage Document Control, Corrective and Preventive Action (CAPA), Non-conformance Reports (NCR), Deviations, Change Controls and Internal Audit systems. Assure the organization is current to cGMP and all other regulatory requirements.
- Interface with procurement as needed to certify suppliers and communicate regarding supplier corrective action as required. Perform Supplier Audits as needed.
- Assist Procurement in compiling supplier ratings on an as needed basis.
- Serve as the company’s Management Representative.
- Troubleshoot any quality concern that may arise within the organization.
- Evaluate customer complaints to provide accurate review and analysis to ensure corrective and preventive actions are implemented in a timely manner.
- Complete Annual Product Review (APR’s) for customer and private label products.
- Anticipate future quality needs and initiate the development and implementation of new approaches.
- Maintain an effective and trained internal audit team. Set audit team schedule and assure timely completion of internal audits.
- Manage and develop direct reports through counseling, performance reviews, and providing training opportunities based on company policies and departmental objectives.
- Establish, track and control departmental goals and objectives.
- Manage the inspection, measuring and test equipment system to include the scheduling of calibrations, calibration standards and all relative records.
- Develop and implement approved annual expense and capital budgets for compliance area and analytical laboratory.
- Establish, track and control departmental budgets and developmental timelines.
- Provide annual cGMP training to the facility population.
- Review and approve all Quality Agreements with customer and/or supplier.
Qualifications
- Bachelor’s Degree required.
- 10-15 years of experience in pharmaceutical and CDMO environment.
- Strong Knowledge of cGMP Requirements Knowledge of current regulatory requirements and industry standards particularly in the areas of manufacturing and packaging, label control, document management and investigations
- Knowledge or experience in Complaint Handling
- Strong knowledge and experience in a highly regulated or FDA environment
- Strong supervisory and leadership skills
- Proficiency with Microsoft Office programs such as Word, Excel and PowerPoint
- Well-organized and detailed oriented professional with strong verbal and written communication skills