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 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