Director of Quality Operations

SUMMARY

The Director of Quality Operations manages and leads the Quality Operations Team to ensure the company’s technical operations are conducted in compliance with the company’s quality and safety guidelines and policies. The Director of Quality Operations is responsible for the management of Quality Assurance, Quality Control, and CMC Regulatory Affairs activities. The Director of Quality Operations will report directly to the President.

DUTIES AND RESPONSIBILITIES

• Ensure quality systems are in place and performing as expected at the site, including the internal audit program, document control, training, product stability, investigations, change control, and corrective/preventive actions

• Provide support to technical operations for projects, investigations, and development of specifications and batch production records

• Review and approve all GMP documents such as SOPs, batch records, specifications, protocols, and reports

• Management of the process of the disposition of materials from raw materials through finished products

• Manage the calibration, preventive maintenance and validation programs and schedules. Coordinate the schedule(s) of technical staff assigned to perform maintenance, calibration, re-certification and validation of selected laboratory instruments.

• Coordinate training and/or assist in training staff when deemed necessary.

• Act as the liaison when interacting with regulatory consultants and regulatory agencies.

• Identify and attend an adequate cGMP training to maintain a current annual certification of this training.

• Compile Quality and EH&S metrics and provide trending to management and staff, including recommendations for areas of improvement

• Review Chemistry, Manufacturing, and Controls (CMC) information for regulatory updates and provide information and feedback for changes to CMC filings

• Responsible for hiring, training, and review of staff

EDUCATION, EXPERIENCE AND SKILLS

Required

• BS or BA and 10 years of experience or combination of training and experience sufficient to discharge the duties of the position.

• 15 years of experience with FDA, cGMP and GLP regulations as they relate to a controlled laboratory and manufacturing environment.

• 15 years of industry background pharmaceutical product development.

• 10 to 15 years of management and supervisory experience.

Preferred

• Previous experience in working with people in a multi-disciplinary team environment.

• Previous experience in technology transfers to contract facilities.

• Previous direct experience with interactions with regulatory agencies.

• Previous experience in the documentation, operation, maintenance, calibration and validation of laboratory equipment in a regulated laboratory environment.

Knowledge and Skills

• Knowledgeable in the overall drug development processes and controls.

• Leadership Skills - develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of CritiTech’s goals and objectives.

• Analytical and Problem-Solving Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.

• Teamwork - the ability to work well and manage personnel in a highly cross-functional team environment.

• Communication Skills - ability to expresses oneself clearly and concisely to customers over the phone or to others within team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience.

• Respect for Others - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.

• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use.

• Resource Management - ability to manage internal and external resources (people, information, technologies, time, and capital); allocates resources appropriately, given organization, group and individual goals and objectives to align with business imperatives.

• Computer skills in relationship to word processing database building and spreadsheet programs also required.