Vice President, Quality & Compliance

Location
Durham, NC
Posted
Sep 29, 2021
Ref
1758366
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

The Vice President, Quality and Compliance is a key strategic position responsible for the design, implementation, management and leadership of Precision BioSciences’ corporate quality systems to support the company’s use of the proprietary ARCUS® editing platform to eliminate cancers and cure genetic diseases. This person is tasked with continually advancing an efficient, risk-based compliance framework.

 

**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.

 

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.  This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

  • Responsible for leadership of Quality Assurance, Quality Control and Training functions. This includes defining and communicating the quality vision and developing a robust organizational structure with a defined succession plan.    
  • Design, implement and manage corporate quality assurance and compliance systems fit for a commercial-stage organization.  Includes authoring or leading development of policies, standard operating procedures and business processes.
  • Assure compliance with internal procedures/ policies and applicable regulatory requirements (US, EU, ROW) and standards.
  • Responsible for disposition of clinical and commercial drug products.
  • Oversee recall and complaint program for drug products.
  • Provide quality assurance (QA) oversight of Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) operations (both internal and external) for production and use of regulated pharmaceutical products.
  • Plan for and host regulatory inspections as well as external partner GxP audits.
  • Maintain quality metrics that monitor progress and ensure high levels of performance and quality are achieved by operational groups. Communicate performance related to these targets to other members of management on an ongoing basis.
  • Lead investigations, risk assessments, creation and delivery of GxP training, resolution of complaints and management of quality issues
  • Qualify and manage relationships with contract research/manufacturing organizations. This includes assurance of the compliance and quality of operations performed by these organizations as well as regulatory inspection support.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

  • B.S. with appropriate training in regulatory requirements, quality systems, inspections and audits and a minimum of 15-20 years related experience. Familiarity with applicable FDA and EMA regulations and guidance documents is mandatory
  • Experience hosting / managing regulatory inspections and external partner audits
  • ­­Experience with multi-year planning, including scenario and contingency plan development
  • Previous experience managing and developing large teams
  • Strong interpersonal skills
  • Problem-solving mindset
  • Outstanding organizational and time management skills

Travel Requirements

  • The Vice President, Quality and Compliance will be expected to travel when needed, both domestically and internationally, up to 25%.

Location

  • This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.

 

 

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs.  For additional information, please visit www. precisionbiosciences.com

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.