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Associate Director/ Director Quality Compliance

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South San Francisco, CA

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Audentes Therapeutics (NASDAQ:BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients. We currently have four products in development, AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM), AT342 for the treatment of Crigler-Najjar Syndrome, AT307 for the treatment of CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), and AT982 for the treatment of Pompe disease.

Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what were looking for, wed love to hear from you. Our compensation philosophy embodies what youd expect from an innovative life sciences employer competing for the best talent available.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes mission.

The Role

The Associate Director/Director, Quality Compliance, reporting to the Vice President, Quality, is responsible for defining and maintaining the Audentes quality system and assuring compliance of the system and activities with Good Manufacturing Practices (GMP) and other applicable regulations related to the production of the Audentes gene therapy biologics. This includes direct responsibilities for systems and activities related to technical compliance and validation, auditing and inspections, change management, and others as well as related training. This role primarily partners with all operations, development, and the other quality functions to build compliance into all Audentes processes and systems and maintain conformance to standards through continued improvement and application of contemporary methodologies. This position will be located in South San Francisco.

The specific responsibilities of this position include:

Manage the Audentes quality function and personnel that establishes and maintains the Audentes quality system and activities to assure conformance to GMP and applicable quality standards

Manage the activities related to Audentes quality risk management programs

Manage the systems that provide oversight to quality system related deviations, change management and CAPA

Perform quality planning, master validation planning, etc. related to quality system and validation activities

Provide management with periodic updates on performance against quality plans and overall quality system and GMP compliance

Maintaining Audentes GMP compliance related activities with current and new regulations, standards, and best practices

Provide compliance and quality system training for the Audentes organization

Coordinate with QA Operations to assure compliant assessment and resolution of discrepancies and deviations

Coordinate with QC and Regulatory to assure the implementation of compliant material and product specifications

Define system to track and manage metrics in support of Site Management Reviews

Coordinates interdepartmental activities for alignment of strategic initiatives and prioritization

May lead investigations, risk assessment discussions, quality system improvement initiatives and resolve potential product quality issues to improve efficiency

Travel (approximately 10-15% with some international) may be required

Required Education, Skills and Experience

Bachelors degree in Biological or Technical/Engineering Science or equivalent with 7 years in a GMP biopharmaceutical manufacturing environment in a quality and/or compliance management role

In-depth knowledge and experience in the application of the principles and guidelines for FDA cGMP and international compliance requirements/expectations for relevant biological processes

Working knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment

Expertise in compliance with respect to pharmaceutical/biologics Quality Systems and Quality Risk management

Skilled in problem solving, root cause analysis, decision-making, and corrective action management

Strong interpersonal skills and the ability to facilitate, lead, and work well as part of a cross-functional team

Solid organizational and time management skills

Proven success hiring, leading, managing, and developing staff

Excellent written and verbal communication skills

Company info


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