Quality Compliance Manager

Quality Compliance Manager

Labtech is a highly specialized recruiting firm that concentrates our efforts primarily on the placement of scientific professionals.  We serve clients in the clinical, pharmaceutical, food & beverage and medical industries, to name a few.  We have been in business for nearly 15 years and have established a reputation for providing high-caliber candidates in the industries that we serve.  Our client base is diverse and strong, and provides our candidates with a wide array of opportunities within multiple scientific disciplines.  We are currently seeking candidates for this direct hire position as a Quality Compliance Manager in an manufacturing environment.

Job Summary:
Responsible for managing the quality systems to ensure Regulatory Compliance and associated procedures, compliance training, documentation and internal auditing are conforming to FDA/cGMP and industry-specific requirements.

Job Responsibilities:

• Build a culture of cGMP compliance and quality by implementing operational excellence and quality management programs.
• Develop and maintain a site SOP and documentation system.
• Define and implement site compliance quality training plan and ensure a process for documentation and compliance quality training.
• Responsible for FDA drug submissions and annual registrations for new and modified OTC products.
• Ensure facility plans are in place for receiving inspectors (FDA, Weights & Measures, Kosher) and managing external audits.
• Responsible for roles and responsibilities of all site personnel in conducting FDA visits and external inspections.
• Participate in decisions regarding out-of-specification matters and review results of corrective/preventive action plans to ensure cGMP compliance.
• Ensure establishment of a change control procedure.
• Establish site cross-functional internal audit teams, document adverse findings, develop corrective action plans and follow-up to ensure compliance.
• Collaborate with Marketing and R&D in developing new product plans that ensure new products are of high quality and readily manufacturable with appropriate clinical research and stability studies to ensure safety and effectiveness.
• Maintain awareness of current FDA matters and provide regulatory opinion through the use of external consultants and trade associations.

Requirements for Quality Compliance Manager:

• BS in Chemistry, Engineering or technical field
• 3-5 years of Quality Leadership experience in pharmaceutical, cosmetic or consumer products industries
• Familiarity with OTC drug submissions and FDA site visits/inspections
• Familiarity with cGMP (CFR 21 - Parts 210 & 211) and CTFA guidelines.
• Ability to create and deliver cGMP compliance and quality training.

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Keywords:  Quality Compliance, pharmaceutical, cosmetic, personal care, PCPC, CTFA, FDA, cGMP, Chemistry