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.

• 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).