Associate Director / Director, Quality Assurance

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Job description

We are Genetic Navigators bringing together passionate, creative and dedicated professionals to join a rapidly-growing start-up on our mission to translate novel genetic insights into lifesaving medicines.

We are seeking an experienced Associate Director / Director of Quality Assurance (QA) who will provide QA leadership to plan, manage, oversee, and conduct GxP quality assurance and compliance activities in support of Maze Therapeutics' clinical development programs. This individual will lead the development of a quality management system which includes quality operations oversight, SOPs and controlled document management, records management, training, and inspection readiness and facilitation. This individual must have the ability to work in a fast-paced, team-oriented, start-up environment. The successful candidate will interact with cross-functional study teams, functional management, and the Clinical Development Leadership Team.

The position will report to the VP of Clinical Development Operations.

Your Navigation Tools:

• Leads the development, implementation, and maintenance of a "fit for purpose" GXP focused quality management system to meet the evolving needs of Maze Therapeutics' clinical development pipeline and studies
• Partner with Clinical Development Operations to provide QA oversight of Ph I - III clinical trials to ensure compliance with GXP, regulatory requirements, study protocols, and Maze SOPs
• Establish, maintain GXP SOPS, work instructions, and any other controlled documents in collaboration with key clinical development functions and stakeholders
• Develop and deliver GXP and quality training for all personnel involved with Maze clinical development programs; identify areas of quality training needs to ensure continuous improvement and adoption of industry best practices regarding quality and GXP compliance.
• Conduct and/or manage qualification inspections of GXP service providers, clinical investigator sites, internal GXP audits, relevant study document audits (i.e. CSRs, TMF)
• Lead GXP inspection readiness activities at investigative sites and at Maze in collaboration with Clinical Development Operations; facilitate mock inspections as needed; facilitate and host health authority inspections in collaboration with Regulatory
• Collaborate with Regulatory to review and assess the impact of any Clinical Development related audit and inspection findings.
• Participate in recommending audit responses and developing/implementing Corrective and Preventative Action Plans (CAPAs) from audits and inspections; monitor all relevant CAPAs from audits and inspections to achieve timely closure
• Represent QA in assigned projects and cross functional teams
• Maintain contemporary knowledge of current agency and industry trends, standards, and best practices related to GXP and compliance.
• As the clinical development pipeline expands, hire and manage additional QA personnel according to business needs

Your role in Navigating the Maze:

• B.A. or B.S. in a scientific discipline and 8+ years of relevant experience in biotech or pharma clinical quality assurance and compliance.
• Strong and demonstrated understanding, interpretation and implementation U.S. Code of Federal Regulations, European regulations, and any other relevant global GxP regulations governing clinical research conduct
• Demonstrated in-depth experience of establishing, refining, and maintaining QA related systems
• Adept in training and implementation of GXP and quality procedures
• Experience with hosting, leading, and supporting FDA, EMA, and global regulatory inspections (i.e. sponsor, vendors, investigative sites).
• Experience with drafting responses and implementing corrective and preventive actions to address audit and inspection observations.
• Experience with CAPA management and root cause analysis methodologies
• Experience with electronic Quality Management Systems and eTMFs systems
• Track record of effective collaboration on internal teams and personnel as well as external partners
• Strong strategic planning and organizational skills, including the ability to support and prioritize multiple projects.
• Excellent leadership and communication skills (written & oral)
• Management experience, particularly with team building, professional development, and mentoring of junior staff
• Positive and enthusiastic disposition, and high personal and ethical standards in approaching corporate goals
• Ability to travel domestically and internationally to critical QA activities (i.e. site inspection readiness) as well as attend relevant industry conferences and workshops