Director of Quality

Salary Range: $ To $ Annually

The Director of Quality is amemberof the senior staffandas suchis alsoexpectedto 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 improvethequalityofworkandjobsatisfactionfor

ProMedpersonnel. Qualityhastheauthorityto halt production if product quality is suspect. The Director of Quality ensures Pro Med’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Positiondutiesandresponsibilitiesinclude,butarenotlimitedtothe following:

• Ensuring that quality and regulatory requirements are established implemented and maintained in accordance with the current ISO
  13485 Standard, and FDA
  21CF
  R820,21
  
  CFR 210 & 21 CFR 211 regulations;
• Ensure the Quality Management System activities are developed and deployed in an efficient and effective manner;
• Oversee 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/ISO
  13485 training programs;
• Oversee the audit program (Customer, FDA, Internal);
• Oversee the Document Control process;
• Oversee 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;
• Oversee product release activities and disposition;
• Lead employees through career planning via performance reviews and goal setting;
• Management Representative;
• Establishes and tracks Pro Med and Pharma quality objectives and reports on the status of the quality management system to the rest of senior management.
• Other duties as assigned;

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Master’s degree or advanced degree in business or business leadership.
• Bachelor’s degree in chemistry, biochemistry, engineering, healthcare, 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 Product 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.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.

• Exposure to heated/air conditioned, ventilated facilities with fluorescense lighting;
• Exposure to buildings where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job:

• The…