Director of Quality, 503A

Job Description

The Director of Quality - 503A will serve as the head of quality for the Pharmacy's Compounding Pharmacy. The Director of Quality – 503A will (1) direct and monitor all daily operational activities relating to the quality of our compounded products, (2) ensure that the drug preparation process complies with government regulations and standards, and (3) is responsible for all regulatory audits pertaining to quality standards for a 503A compounding pharmacy, including (but not limited to) preparation of an audit, leading the audit, follow-ups with any agency, and working through corrective and preventative actions related to an audit.

Duties And Responsibilities:

• Ensures quality and regulatory standards are met for state regulatory bodies and adhere to USP <795>, USP <795> and <800> guidelines. 
• Oversees and facilitates all regulatory audits and requirements for 503A compounding pharmacy (state and accredited services), including conducting audits in an ISO classified cleanroom and/or controlled labs as needed.  
• Develops goals and initiatives for the department.
• Manages, reviews, approves, distributes and maintains Standard Operating Procedures (SOPs).  
• Ensures all logs and forms are filled, accurate and on time.  
• Manages batch review team (both quality and pharmacists).
• Manages, reviews, approves, distributes and maintains aseptic technique qualifications and media fill process.   
• Manages, reviews, approves, distributes and maintains equipment and process qualifications as needed. 
• Manages, reviews, approves, distributes and maintains operating procedures and specifications.   
• Manages, reviews, approves, distributes and maintains routine change control requests as designated.   
• Manages, reviews, approves, distributes and maintains raw materials and finished product specifications.
• Manages raw material receipt process (from quarantine to release).
• Manages and ensures the preparation testing coordination and submission.
• Creates systems to better meet performance and quality standards.
• Manages raw material and final preparation testing. 
• Creates, implements and strengthens Quality Management Systems.
• Responsible for visual inspection, labeling, and packaging team. 
• Oversee the environmental monitoring (EM) program. 
• Leads Non-Conformance Incidents (NCIs), Deviations and CAPA Investigations as needed. 
• Assists with the analytical analysis for root cause issues. 
• Guides managers on implementing company initiatives and policies.
• Responsible for assisting with the creation of any technical and regulatory documents. 
• Reviews test results and inputs summaries into the monthly and quarterly Quality Assurance report templates. 
• Maintains quality records (equipment calibration and maintenance, training, deviation and complaint investigations).  
• Performs other duties as assigned. 
  
  

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

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices.  The employee is regularly required to move about the office and around the corporate campus.  The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employee must be able to stand and walk for extended periods of time for consecutive days. Employee must be able to lift up to 30 lbs.

Knowledge And Skills

• In-depth knowledge of pharmaceutical regulations (USP <795>, USP <797>, USP <800>). 
• In-depth knowledge of state board of pharmacy regulations (licensed in all 50 states). 
• Effective communication skills, both written and verbal.  
• Leadership skills and the ability to facilitate the work activities of others.   
• Proficiency with computer software, Microsoft Office, SalesForce, and Oracle preferred.   
• Ability to act effectively as a member of a team to resolve problems. 
• Good organizational and time management skills.  
• Must be able to enter the cleanroom and manufacturing space as needed for audits and escalations. 
  
  

Experience And Qualifications

• Bachelor’s degree in technical or scientific discipline.
• 10 years' experience in pharmacy, pharmaceutical or medical device FDA GMP environment.
• 5+ years of leadership experience.   
• 5+ years of experience in Pharmacy Compounding of Sterile Preparations (following USP <797>) required.
• 5+ years of experience in Pharmacy Compounding of Non-Sterile Preparations (following USP <795>) preferred.
• Must have greater than 5 years regulatory Audit experience.   
• Ability to work autonomously within established procedures and practices. 
• Assertive and able to take charge of a situation when appropriate with the ability to lead, motivate and influence others.
• Proven leadership experience managing teams and coaching and mentoring individuals.
• Excellent interpersonal skills: ability to communicate effectively (orally and in writing) with all levels of personnel.
• Strong analytical, problem solving and strategic thinking skills.
• Ability to work effectively in a fast-paced environment with tight deadlines.   
• Excellence, or SQA Registered Quality Assurance Professional.
• Preferred ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational preferred.
• Experience as a compounder.