Job Title: Vice President of Quality
Reports To: President
Location: Oregon (On-Site)
Job Summary:
The Vice President of Quality oversees the combined effort of the Quality Assurance and Quality Control departments. Required attributes include an innovative, results-driven, and broad-minded quality control and assurance executive with extensive experience in compliance and regulations, systems management, deviations, design and development, project management, strategic planning, training, and mentoring, client/vendor relations, performance management, and change management. Extensive experience with laboratory operations is required.
The successful candidate will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.
Supervisory Responsibilities:
Building and leading the Quality Assurance and Quality Control groups Provides constructive and timely performance evaluations
Handles discipline and termination of employee in accordance with company policy
Performs other related duties as assigned.
Duties/Responsibilities:
Implementation and continuous improvement of the company’s quality systems and facility validation
Quality Systems, Deviations, CAPA, EV, Change Control, Document Management, validation, and auditing
Document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
Oversight of investigations
Support of internal audits, client audits and regulatory inspections, as needed
Oversight of a broad range of documentation including, but not limited to User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Change Control, and Risk Assessments
Work with cross-functional teams to troubleshoot equipment, process, and validation issues
All other duties as assigned
Require Skills/Abilities:
Broad knowledge FDA and international regulations related to GMP and Pharmaceuticals
Experience organizing and managing work responsibilities while working independently with minimal oversight
Time and project management skills with the ability to multi-task and meet deadlines
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent organizational skills and attention to detail
Strong analytical and problem-solving skills
Strong supervisory and leadership skills
Ability to prioritize tasks and to delegate them when appropriate
Proficient with Microsoft Office Suite or related software
Education and Experience:
Minimum of a bachelor’s degree, preferably in a scientific discipline. An advanced degree is preferred
15+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry with focus in small molecules
Experience with facility validation activities
Experience with regulatory inspections by the FDA and EU authorities
