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![Empower Pharmacy](https://media.trabajo.org/img/noimg.jpg)
Director, Quality
2 months ago
Position Summary
The Director of Quality - 503A will serve as the head of quality for Empower 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, USP, and 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
Oversees 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 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, USP, USP)
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
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
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
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) required
5+ years of experience in Pharmacy Compounding of Non-Sterile Preparations (following USP) preferred
Must have greater than 5 years regulatory Audit experience
Proven leadership experience managing teams and coaching and mentoring individuals
Excellence, or SQA Registered Quality Assurance Professional
ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational preferred
Experience as a compounder
Benefits
Health/Dental/Vision
Flexible Spending Account (FSA) or Health Retirement Accounts (HRA)
401(k) with company matching
Paid PTO
Paid Holidays
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