The VP of Quality Assurance and Regulatory Affairs will oversee and lead project teams to deliver business results focused on improving production processes to improve reliability, increase simplicity and enable growth. The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients and peers.
The VP of Quality Assurance and Regulatory Affairs will meet manufacturing and company goals in staff development, safety, product quality, production efficiency, and leadership. This position will ensure the operation of the facility and the equipment are in compliance with standards, promulgated under Sections 503A and 503B of the US Food, Drug & Cosmetic Act, OSHA, environmental, labor, and other governmental laws and regulations, while following appropriate documentation and quality systems.
• Implement and ensure compliance with US Food, Drug & Cosmetic Act, Section 503A and 503B, 21 CFR parts 210 and 211 and all its related elements such as facilities, documentation (SOPs and validation protocols, etc.), training, reports and records
• Oversee and lead quality systems activities such as metrics, safety, logbooks and documentation management, safety programs, risk assessment management, etc.
• Oversee, manage and implement strategies to identify, monitor and resolve regulatory issues, including, but not limited to: communication of CMC regulatory requirements, assessment of regulatory compliance, development and implementation of regulatory CMC strategies, and management / compliance with all reporting requirements.
• Implementation and management of a variety of complex 503B quality systems documentation in multiple technical areas, including SOPs, forms, checklists, etc…
• Oversee and manage the authoring of quality/CMC related regulatory documents to support validation and commercial production.
• Serve as Corrective Action and Preventative Action (CAPA) owner to address operational issues and investigations that directly impact production
• Implement and manage the development of analytical methods and batch release protocols
• Oversee the quality control unit’s responsibility for discrepancy and failure investigations and the development and oversight of appropriate corrective actions and preventive actions regarding the following:
• Rejected lots of finished drug product, including initial positive sterility tests or out-of- specification results for attributes such as endotoxin level, assay, impurities, particulate matter, or reconstitution time, if applicable and regardless of batch disposition
• Unexpected results or trends
• Failures that occurred during validation or revalidation of sterilization or depyrogenation processes, including media fill/process simulation failures
• Stability failures, including failures of quality that are determined to have other causes than degradation of the drug product
• Environmental and personnel monitoring results that exceed alert or action limits
• Process deviations or equipment malfunctions that involve critical equipment.
• Returned goods that indicate possible drug product contamination or other risks to 766 patients (e.g., hazy or cloudy drug product, foreign matter/particulates in injectable drug 767 products, cracked or leaky containers)
• Oversight and management of the quality control unit’s periodic review records of compounding operations to evaluate the quality standards for each drug product to determine the need for changes in specifications or control procedures (§ 211.180(e)). As part of this review, the quality control unit should identify trends and evaluate quality indicators such as:
• For aseptic processing, all media fills/process simulations performed since the last review
• Results of environmental monitoring
• Results of personnel monitoring
• Results of water system testing, where water is used as a component in the drug product and is purified/processed on-site
• Results of finished drug product testing
• Periodic scrutiny of operations to ensure adherence to procedures and proper aseptic technique
• Oversight and management of the quality control unit’s responsibility for evaluating written and oral complaints concerning the quality or purity of, or possible adverse reactions to, a drug product. Complaint handling procedures must include a determination as to the need for a full
investigation and provisions for review to determine whether the complaint represents an adverse event that must be submitted to FDA (see §§ 211.198 and 310.305, and section 503B(b)(5) of the FD&C Act)
• Implementation and ongoing support of U.S. FDA compliant manufacturing of aseptic drug products
• Oversee pharmaceutical formulation testing, including lot monitoring and outside testing vendors
• Responsible for any recalls at all pharmacy locations, including managing the recall process and archiving all recall data
• Assist with the technical requirements of supply agreements and other external contracts
• Facilitate and develop cross-site communication and information sharing to ensure implementation of industry best practices
• Oversight, management and strategic planning of the departmental budget
• Support implementation of project within budgets and timelines
• Develop weekly/monthly goals and schedules to manage activities and team
• Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure
• Serve as an expert in multiple areas and provide information and training to other employees
• Perform duties in accordance with established company procedures and policies; perform other duties as assigned
Required Education and Experience
1. Bachelor’s degree in Science or Engineering or related field or equivalent work experience required 10+ years of progressive experience within a cGMP and or a 503B outsourcing facility
2. A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices
3. Established knowledge and understanding of US and International regulatory guidelines and regulations
4. Familiarity with manufacturing processes and operations, automation, equipment/facilities validation
5. Ability to complete tasks with little direction or need for supervisory follow-up
6. Strong written, verbal and presentation communication skills
7. Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other must be able to learn additional software as required)
8. Ability to think creatively in confronting new issues and pursuing novel approaches to old problems
9. Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
Work Environment/Physical Demands
Level 1: Office Environment.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. A portion of the work may be performed in the plant or warehouse where the noise may be loud.
Possible exposure to chemicals. Use of PPE might be required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Where additional duties are permanently assigned (for example, vendor qualification), these will be described in an attached sheet.