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

Hobson Associates jobs

Vice President of Quality