Vice President, Quality

Akebia Therapeutics•Cambridge, MA

About The Position

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary: The Vice President of Quality reports to the Chief Technology Officer (CTO). As the leader of Akebia’s Quality organization, this individual’s primary responsibility is to develop and oversee Akebia’s clinical and commercial quality strategy, Clinical and CMC quality operations, global quality systems, training and auditing to ensure organizational compliance with global regulatory requirements. The incumbent will have overall responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately in a fast paced, rapidly growing organization .

Requirements

A minimum Bachelor’s degree in a scientific discipline is required. An advanced degree in a scientific discipline is preferred.
15+ years progressive responsibility in the pharmaceutical/biotech industry (experience in GCP/GLP/GMP, required).
10+ years of Quality leadership and management experience, with a successful track record.
Leads by example and highly collaborative with the proven ability to work in a cross-functional team. Flexible.
Experience in small molecule development required. Experience in biologics development preferred.
Experience in the development, approval and life cycle management of products supporting a variety of worldwide markets.
Understanding of worldwide GxP requirements and quality systems for clinical and commercial products.
Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
Ability to work successfully with contract manufacturing (CMOs) and research organizations (CROs).
Experience interacting with regulatory health authorities at pre- and post-approval inspections.
Ability to contribute to quality and compliance decisions or to seek expert advice, if necessary, on a wide range of topics.
Commitment to operational excellence.
Ability to travel approximately 20% to various meetings including overnight trips. Some international travel may be required.

Responsibilities

Defines and drives the Quality vision and culture of the entire company in close collaboration with the executive leadership team (ELT).
Defines clear Quality objectives and cross-functional completion of responsibilities; uses judgment to develop solutions and drives risk analysis and mitigation strategies.
Ensures an appropriate employee training program is in place to support GxP activities and to maintain regulatory compliance.
Ensures appropriate quality assurance and control systems are in place to support clinical and commercial product release in a compliant and timely manner. Routinely monitors performance to established targets.
Oversee the development, maintenance and management of quality systems that conform to applicable US and international regulatory requirements.
Oversees all aspects of Quality related to the manufacture and testing of small molecules and biologics.
Provides leadership, guidance, and direction to clinical and CMC quality staff consistent with GxP requirements, including quality assurance, quality operations, clinical quality, supplier quality, quality training, and quality control groups.
Defines the necessary staff structure and hiring to ensure Quality vision and objectives can be achieved.
Interacts with manufacturing, regulatory, non-clinical, and clinical operations and other functional management as they impact the quality operation.
Evaluates and approves compliance documentation including regulatory filings for clinical and commercial products.
Drives continuous improvements within the Quality organization.
Develops and manages the annual budget for the Quality organization.