CQA Engineer

Roles & Responsibilities: Provide an active role within R&D as an expert in GCP requirements. The strategic focus is for early detection and prevention, followed by correction of issues. Collaborate with GCP functional areas and assist in the resolution of external partner quality issues. Lead or participate in technically complex and strategic cross functional GCP projects. Lead or participate in GCP focused strategic initiatives to improve compliance with regulatory requirements and standards. Lead or participate in process improvements, including review / update current supporting processes and procedures. Achieve a difficult balance of involvement, independence, and objectivity. May support Clinical Quality Agreement creation and periodic review. Consistently demonstrate Client's Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality. Requirements: Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries. Thorough understanding of international GCP regulatory standards. Must have a technical background and extensive knowledge of worldwide requirements for quality systems. Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills and sound judgment. Persuasive, effective communication skills are essential with an ability to work effectively across GCP functions, across technical areas and outside of the company. Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM), Registered Quality Assurance Professional (RQAP), and/or Certified Quality Auditor (CQA).