Remote Quality Assurance/GMP/CMC SME

We have a newly created remote opportunity for a Quality Assurance/GMP/CMC Subject Matter Expert. In this role, you will establish and manage phase-appropriate Quality Management Systems to support client development activities and maintain compliance with regulatory expectations.

Organization: My client is a partially employee-owned (ESOP) scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:

• Lead Quality Assurance oversight of client-outsourced CMC development programs, including interfacing with vendors (CMOs, etc.), review/approval of GMP documentation, lot dispositioning, maintenance of CMC documents, etc. 
• Draft and negotiate Quality Agreements with client vendors and suppliers.
• Oversee GMP vendor qualification, including the design and use of questionnaires and the execution of GMP site audits.
• Review and maintain controlled documentation to ensure compliance with specifications, master and executed batch records, test methods, protocols, and reports. 
• Lead investigations, release batches and assign lot dispositions.
• Develop and maintain stage-appropriate quality management systems for clients to meet all regulatory requirements for development and commercial activities.
• Author and review Standard Operating Procedures.
• Interact efficiently with managers and other functional groups to identify issues.

Requirements & Experience:

• Bachelor’s degree in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
• A minimum of 10-15 years in the pharmaceutical/biotechnology industry and/or consulting with at least 6 years in Quality Assurance relating specifically to the oversight of CMC development.
• Consulting experience and RQAP certification are preferred.
• Experience in outsourced development program quality oversight and auditing.
• Excellent understanding and stage-appropriate application of GMP regulations and ICH and FDA CMC and Quality guidance documents.
• Demonstrated organizational and project management skills
• Strong computer skills (e.g. Microsoft Word, Excel, PowerPoint, etc.).
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

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