The Director, Commissioning, Qualification and Validation (CQV) will be responsible for strategy, direction and execution of CQV activities and will be accountable to operate and grow the CQV group within the consultancy. Reporting directly to the Managing Partner, the Director will be a key member of the management team and will provide leadership to form a CQV center of excellence within the Mid-Atlantic region.
Essential Duties and Responsibilities
- Apply expertise in CQV services to the regulated healthcare and life sciences industry – Pharmaceuticals, Medical Devices, Supply Chain, CMO, CRO.
- Serve as senior Subject Matter Expert on CQV issues/hot topics, with ability to identify and present to an industry audience current areas of concern and/or interest - remaining current with changing process, technology, and regulatory developments.
- Develop and manage a portfolio of customer accounts, develop new business, hire the right team of CQV associates/engineers, and oversee multiple projects concurrently.
- Work with customers’ multi-disciplinary engineering/capital project teams, ensuring in-scope project objectives are met on-time and on-budget. Communicate proactively with both internal and external stakeholders and senior management regarding progress, issues, and plans for resolution.
- Oversees the development and execution of CQV strategies, policies, and procedures; ensures that projects are executed and all deliverables are generated in accordance with customer policies and practices.
- Provide leadership and technical guidance on all CQV matters including the hiring, managing and developing of CQV associates/ engineers.
- Bachelor’s Degree or higher in Engineering or related scientific discipline.
- Ten (10) plus years of experience in CQV for pharmaceutical, biotechnology or medical device manufacturing equipment, automation, processes & facilities including managing others; Computerized Systems Validation (CSV) experience.
- Prerequisite knowledge, skills and abilities, as well as business acumen, to effectively build client relationships, secure new business and successfully manage multiple projects.
- Highly motivated and flexible; Adaptable to a fast-paced, changing environment requiring effective interpersonal, client-facing and teamwork skills in with Azzur core values.
- In-depth understanding of CQV technologies and proficiency with MS Office software
- The ideal candidate is based in the Mid-Atlantic region (NJ-PA-DE-MD) and flexible about business-related regional travel, seeking in-person customer interaction on a frequent-basis.