R&D Quality Manager

Job Description

Manager, Development Quality Assurance

The Manager, Development Quality Assurance will play a key role in managing QA and Regulatory Compliance activities for development products. In coordination with Associate Director, specific areas of responsibility include: Release of GMP Product, managing phase appropriate compliance, interfacing with contract manufacturers, and QA Representation on development teams.

• Represent QA function and lead QA decisions on development projects by reviewing associated investigations, deviations, validations, executing audits, supporting Quality Agreements, reviewing batch records, and establishing vendor QA relationships.
• Support GMP compliant supply for development products and clinical studies including placebo, comparatory, and development products.
• Write QMS SOPs as required for outlined responsibilities.
• Assist with training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and manufacturing records
• QA release or rejection of Development and Clinical Trial Materials
• Execute internal and supplier GMP audits for development materials.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
• Manages and coordinates the QA operations of assigned groups and plan, direct and monitor results. Approves requests and establishes goals and timelines.
• Reviews and approves technical reports and qualifications relating to the development group and projects.
• Communicates frequently with personnel, across functions and with outside representatives to ensure expectations are met and a customer service focus is maintained.
• Oversees the training and development of personnel to insure an adequate and competent staff is available to handle assigned tasks.
• Oversees the activities QA group providing support developmental work. Provides support as required to development, analytical and R&D projects. Regularly participate in project meetings with customers and R&D group, to determine root cause and corrective actions, as well as batch disposition. Resolve technical issues in collaboration with Senior QA Management.
• Manages the preparation of SOP’s, standards, specifications, interoffice memos and reports for the R&D group. Participates in the formulation of recommendations that solve quality problems or improve quality in the R&D area.
• Ensures regulatory compliance and a safe and healthy work environment within the function. Follows safety policies and procedures.
• Performs other duties as assigned or required by business needs. Supports and participates in FDA or other regulatory agency inspections.

Education & Experience:

• BS degree in Chemistry, Life Science or related science field preferred

Experience Requirement:

• A minimum of 10 years of relevant Quality Assurance experience working in research and development environments
• Knowledge and understanding of phase-appropriate GxP quality standards
• Experience with leading internal and external audits.
• Experience reviewing API and drug product batch records.
• Experience reviewing development and clinical packaging batch records
• Experience releasing development and clinical drug supplies.
• Experience reviewing validation documents.
• Experience with Quality review of IND related documents.
• Full understanding of cGMPs, clinical phased approach of GMPs, and a working knowledge of GCPs for pharmaceutical products.
• Experience of pharmaceutical product manufacturing processes and analytical laboratory practices.
• Demonstrate ability to independently manage projects and variable workloads.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (MS Word, MS Excel, MS PowerPoint, MS Outlook).
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.