Director Pharmaceutical Quality Systems

Overview

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.  The Director, Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.

External US

 

Summary of Position:

The Director, Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.

 

Reports to: Head of Quality

Location: Thousand Oaks, CA

 

Major Activities & Responsibilities:

• Manages the Quality Systems and Compliance functions including Deviation, CAPA, Change Control, Risk Management, Training, Document Management, Validation (equipment and CSV), Supplier Quality (material suppliers and service provides), Regulatory and Management programs.
• Lead Quality Systems and Compliance; own strategy to support business requirements.
• Drive GMP system and process continuous improvement initiatives.
• Responsible for training of Quality Systems and Compliance team members. Ensure a robust and effective site training program.
• Maintain policies, standards and procedures for the Quality Systems and Compliance functions.
• Oversee development of metrics and Management Review.
• Act as Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
• Leads GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
• Anticipates and resolves problems effectively.
• Expert in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities.
• Provides guidance in the subject of aseptic technique/operations, clean room procedures/processes, environmental monitoring programs, and aseptic process simulation studies.
• Ability to perform in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
• Supports other GXP assignments as required.

 

Education / Experience:

• 8+ years of team management experience
• Master of Science (M.Sc.) or PhD with 10+ years of experience; or
• Bachelor of Science (B.Sc.) with 13+ years of experience; or
• Associate Degree with 16+ years of experience

 

Behavioral Competencies:

• Advanced communication skills
• Self-starter (advanced skill)
• Advanced problem solving skills
• Advanced critical / logical thinking / analysis skills
• Advanced risk management skills
• Advanced project management skills
• Advanced time management skills
• Advanced conflict resolution skills
• Advanced teamwork and collaboration skills
• Advanced negotiation skills
• Advanced innovative thinking skills
• Advanced decision making skills
• Advanced people management/ development skills
• Advanced strategic leadership skills
• Customer service-oriented
• Goal/ results oriented
• Detail oriented

 

Technical Competencies:

• Mastery knowledge of cGMP
• Mastery knowledge of aseptic techniques
• Mastery knowledge of biopharmaceutical operations
• Mastery knowledge of quality systems
• Working knowledge of computer applications
• Mastery knowledge of GXP enterprise systems
• Mastery knowledge of regulations and compliance
• Masterly knowledge of creating and approving technical documentation
• Advanced knowledge of process and method qualification
• Working know