VP, Quality

Location
South San Francisco, California, United States
Posted
Aug 24, 2019
Ref
52
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Purpose:

The purpose of this position is to provide leadership in developing Principia's Quality Management and Compliance Systems as the company progresses into phase III product and clinical development, and commercial operations. Working in a virtual business model, the incumbent leader will be responsible for leading seanior directors of Manufacturing and Clinical Quality in 1) Establishing quality and GMP, GLP & GCP compliance strategies; 2) Developing and maintaining systems to assure the quality of drugs, nonclinical and clinical studies through collaboration with the heads of those functions; 3) identifying and implementing eSystems to manage product and study quality; 4) Establishing metrics, and reporting outcomes to executive management. As a small star-up company, in addition to providing strategic direction the incumbent will be expected to perform detailed tasks to produce the department's deliverables.

Responsibilities:
• Policies, Standards and Culture:

o Establish quality policies and standards, that will protect the company's assets and meet requirements of all government agencies in the territories where Principia does business.

o Lead, coach, facilitate, and support problem-solving, analysis of results and continuous improvement activities.

o Establish a culture where the organization sees working with government agencies such as the FDA as a learning opportunity and effective partnership.
• Drug Manufacturing

o Direct and motivate the Senior Director of the Drug Manufacturing Quality unit in their duties related to manufacture of active pharmaceutical ingredient (API), bulk drug product (BDP), investigational medicinal product (IMP) production. This includes contractor qualification management, quality agreement negotiation, product and process validation, regulatory submission review, approval of drug manufacturing control documents (specifications, master batch records, change controls, deviations, etc.), quality investigations and batch disposition.
• Nonclinical and Clinical Studies

o Direct and motivate the Senior Director of the Nonclinical and Clinical Study Quality unit in their duties related to conduct of animal and human studies of the toxicity and efficacy of Principia's drug candidates. This includes contractor qualification management, quality agreement negotiation, study quality and integrity risk assessments, regulatory submission review, study auditing, etc.
• Quality Monitoring:

o Establish systems for monitoring the quality of outputs from the manufacture of drugs, and the conduct of nonclinical and clinical studies, such as quality metrics and auditing.

o Establishing Corrective and Preventive Action (CAPA) management systems.
• Competent Authority Inspections:

o Maintaining systems and operations in a state of GMP/GLP and GCP inspection readiness.

Personal Attributes:

Operating as a role model, the ideal incumbent will provide guidance and coaching to executive management and the Quality & Compliance unit that will build a culture of quality that will permeate all levels of the organization. S/he will 1) pursue business and cross-functional acumen that aligns with the future direction, opportunities, and challenges of Principia's business and the biotech industry; 2) bring a broad business perspective to problem solving, leveraging depth and breadth of expertise to contribute to solving complex organizational (and not just functional) business problems; 3) build bridges between knowledge from a wide variety of sources to create or realize business opportunities; 4) transfer expertise to potential successors; 5) make decisions through weighing up the cost-benefit and risk implications; 6) act like an entrepreneur on long-term (beyond 12 months) opportunities and problems to make performance gains, formulating completely new and 'off the wall' ideas and concepts, which create a potential opportunity, using innovative approaches to allow them to be realized. These may address underlying needs that have not yet been identified by colleagues; 7) speak out for a course of action even when others disagree. Take significant and appropriate personal or professional risks to accomplish important goals; 8) challenge others with respect.

Qualification Requirements:

The position requires a B./M.Sc./Ph.D. in chemistry, chemical engineering, pharmacy or equivalent; 15+ years of experience in pharmaceutical development with an ethical pharmaceutical company with 5+ years of experience leading a Quality unit; a thorough knowledge of scientific quality by design principles; validation; current and strong working knowledge of US and EU GxPs; ICH and quality guidelines; Part 11 requirements; and demonstrated success in quality oversight. Candidates must demonstrate expert problem solving, organizational, planning, prioritizing, decision-making, as well as exceptional communication (written and oral), negotiation and influencing skills. This position may require up to 40% travel.