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Senior director quality assurance


This is a Full-time position in San Francisco, CA posted December 12, 2019.

The Sr.

Director/Head, GMP Quality Assurance will be responsible for strategic and operational management of manufacturing, testing laboratory, and release and distribution-related Quality activities. The scope of this leadership role includes oversight of GMP activities at Angion and its contract development and manufacturing organizations (CMOs), suppliers (?), testing laboratories, and logistics vendors. The Senior Director of GMP QA is accountable for ensuring that vendors are compliant with global regulations, prepared for potential Sponsor and Regulatory Inspections and that the appropriate processes, systems and activities are in place and performed to protect patient safety, product quality, and data integrity.This is an exciting, interdisciplinary role for a highly qualified and motivated individual.

The successful candidate will have a strong understanding of GMP Quality for raw materials, drug substance, drug product, and label and packaging, including QC testing, stability, and distribution. This expertise, along with drug development background and the organizational and interpersonal skills required to build and foster strong relationships with collaborators, will be needed for success.

The ideal candidate will demonstrate the ability to be both detail oriented and to think strategically.This individual will work to continuously improve GMP quality processes and to support the state of GMP compliance at Angion. The position will focus initially on GMP Quality build-out to strengthen Clinical-phase Quality Systems, ensuring that systems and processes developed will accommodate global, Commercial Quality system requirements within the near-term. The result will be pre-approval and routine Regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities.The position is based in San Francisco, CA, and reports to the VP, Program and Alliance Management and Quality Assurance (located in Boston).

 The Sr.

Director/Head, GMP Quality Assurance will:Lead group that provides QA oversight of GMP activities at Angion and its contract development and manufacturing organizations (CDMOs), testing laboratories, and logistics vendors.Develop and implement risk-based Quality strategies for investigational and commercial materials including establishment and maintenance of phase appropriate quality systems; proactively identify and mitigate quality risks.Be responsible for quality-related activities and requirements to enable release of raw materials, drug substance, drug product, and finished goods.Oversee GMP/GDP vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations/ guidelines and are prepared for Regulatory inspections.Lead development, implementation, and maintenance of GMP Quality Systems and SOPs related to GMP/GDP activities.Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with investigations, deviations, product complaints and recalls. Provide quality input and oversight for process validation, process performance qualification, and continuous process verification.Oversee commercial distribution, logistics, and launch activities.Collaborate with Technical Operations colleagues and the Sr.

Director/Head, Global Quality Systems and Compliance to establish metrics and report the state of GMP Quality and compliance of GMP vendors to senior managementEnsure Technical Operations and GMP/GDP vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standardsStay abreast of industry developments – forthcoming regulations, guidance, best practices, and etc., training and mentoring staff on global GMP regulations and guidance.Ensure pre-approval and routine Regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities. QualificationsThe successful candidate possesses:Minimum BS degree in Science or Engineering, advanced degree a plus, and 15 years of applicable pharmaceutical drug development experience with at least 10 years of Quality Assurance experience, including Supply Chain QA. Useful background could include experience with small molecules, parenteral aseptic fills and filing of an NDA.Demonstrated success leading and motivating cross-functional teams and managing direct reports.Track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.Strong working knowledge of global GXP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.Excellent leadership skills including an effective written and oral communicator, including experience preparing and making presentations to executive level management and interacting effectively with internal and external organizations, collaborators, and customers.Willingness to travel up to approximately 25%.