QA Supervisor, Change Control

Proclinical is currently recruiting for a QA Supervisor of Change Control with a multinational biopharmaceutical company located in Raritan, NJ. As the QA Supervisor, you will provide quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.

Job Responsibilities:

• Lead efforts to establish and streamline the site change control process.
• Act as the change control champion by owning the change control process from initiation through completion.
• Schedule and manage the site change control review board meetings.
• Manage change control metrics reporting.
• Collaborates with functional departments to resolve issues.
• Support drafting of standard operating procedures.
• Manage cross-functional projects with many stakeholders.
• Participate in the training program for new members.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Review and approve change controls, SOPs, and other documentation.
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
• Drive continuous improvement.
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Detailed knowledge of Quality and Compliance standards.

Skills and Requirements:

• Minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
• Minimum of 6 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred. A minimum of 1 year of leadership experience is also required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience directly supervising employees is preferred.
• Ability to work with and lead others in a team environment.
• Experience developing and setting long-term objectives.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Experience reviewing/auditing documentation including but not limited to: Batch Records, SOPs, Work Instructions, Validation protocols.

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or m.phelan@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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