Director of Quality
About The Position
The Director of Quality is a member of the senior staff and is expected to participate in senior staff and management review meetings, actively identify and pursue new business opportunities, contribute ideas into the overall management and well-being of the company, serve as a mentor to junior staff, and consistently identify and implement new ways to improve the quality of work and job satisfaction for ProMed personnel. Quality has the authority to halt production if product quality is suspect. The Director of Quality ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
Requirements
- Master’s degree or advanced degree in business or business leadership.
- Bachelor’s degree in chemistry, biochemistry, engineering, health care, biological sciences, or a related scientific discipline.
- Must have 15 years minimum of quality assurance and regulatory compliance experience in either the development or manufacturing of pharmaceutical and/or combination products.
- Must have hands-on pharmaceutical, Device and Combination Products cGMP experience.
- Technical understanding of Medical Device & Pharmaceutical industry language and contracts.
- Expert knowledge of FDA regulations (21 CFRs 820, 210 & 211), QMS Standard (ISO 13485), Risk Management standard (ISO 14971), ICH, and USP requirements.
- Knowledge of analytical lab activities, validations, and data analysis.
- Strong oral and written communication skills with a demonstrated ability to work in a team environment.
- Strong leadership skills.
- Ability to be flexible, multitask, and deliver on multiple projects simultaneously.
- Proficient computer skills, including MS Word, MS Excel, MS-PowerPoint, and MS-Outlook.
Responsibilities
- Ensuring that quality and regulatory requirements are established, implemented, and maintained in accordance with the current ISO 13485 Standard, and FDA 21 CFR 820, 21 CFR 210 & 211 regulations.
- Ensures the Quality Management System activities are developed and deployed in an efficient and effective manner.
- Oversees the approval or rejection of all components, in-process product/materials, packaging materials, labeling, and drug product.
- Oversee review and approval or rejection of all controlled documents (procedures, specifications, etc.) that impact product quality.
- Oversee the supplier qualification process.
- Oversee the cGMP/QSR/ISO13485 training programs.
- Oversee the audit program (Customer, FDA, Internal).
- Oversees the Document Control process.
- Oversees Validation activities (Equipment, Process, Clean Room).
- Oversee the review of production records and associated documentation (prior to product release) and assures issues or errors are fully investigated.
- Oversees product release activities and disposition.
- Leads employees through career planning via performance reviews and goal setting.
- Management Representative
- Establishes and tracks ProMed and Pharma quality objectives and reports on the status of the quality management system to the rest of senior management.
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
