Site Head of Quality

Job Description Our client is a U.S. pharmaceutical company with a focus on Women's Health. Overview: The Site Head of Quality provides leadership, direction and quality oversight for our Holbrook manufacturing site. This position is responsible for the development, implementation and maintenance of quality assurance systems and activities and will collaborate closely with team members at all levels to ensure compliance with all relevant cGMP regulations and guidelines. This individual will provide QA expertise and guidance in support of the development and product quality strategy and will be responsible for execution of the day-to-day quality activities. This role reports to the Chief Operating Officer. Principal Duties and Responsibilities: Effectively manage resources within Quality department in a manner that supports the delivery of the company's goals and objectives for regulatory compliance and product quality. Provide strong leadership and support to quality team members ensuring a collaborative, positive team environment. Monitor manufacturing operations for compliance to regulations, SOPs and batch records. Ensure products are always manufactured according to batch records and within cGMPs. Ensure the site maintains a state of 'continuous' regulatory inspection readiness, including preparation for, participation in and follow up on inspections by regulatory authorities. Interact with CDMO customer contacts on quality and operational matters. Verify manufacturing operations are following Good Manufacturing Practices (GMPs), as outlined in the CFR, FDA Guidance Documents, ICH guidance documents. Coordinate resolution of vendor related issues. Review and approve manufacturing protocols, qualifications, and summary reports. Collaborate with the investigations department to ensure quality related issues are resolved thoroughly, in a timely manner, and incorporate cross functional processes to determine root cause. Participate in internal and external audits. Analyze data to identify areas for improvement in the quality system. Other duties as assigned. ?Job RequirementsQualifications and Requirements: Bachelor's or master's degree in chemistry, biology, pharmacy. 10+ years of experience working in pharmaceutical product manufacturing with experience in compliance, and quality assurance. Direct experience interacting with U.S Food and Drug Administration and other regulatory agencies. Strong knowledge and understanding of FDA cGMP regulations. Experience with and fundamental understanding of FDA regulations and guidance documents. Experience leading GMP audits, and hosting on site FDA inspections covering drug product manufacturing and analytical testing sites. Understanding of process validation and/or IT compliance. CDMO experience preferred but not required. Experience in defending processes, procedures and investigation during regulatory inspections. Strong interpersonal, communication and influencing skills with the ability to foster excellent working relationships across all levels within the organization. Highly effective leadership skills with demonstrated success in building high-performing teams. A true self starter, who works effectively on their own initiative, and is used to working in demanding environments with continuous change and ambiguity. Strong problem-solving ability to evaluate quality matters and make decisions utilizing risk-based approach.Meet Your RecruiterLexie Pierce Senior Recruiter As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives. Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD). Connect on LinkedIn

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