Job Description
Target PR Range: 30-40/hr
*Depending on experience
Job Description:
Primarily responsible for supporting the Research and Development quality agreement process with a focus on identifying and implementing process improvements.
Lead or participate in technically complex and strategic cross-functional projects, demonstrating the ability to work across various teams.
Drive or support strategic initiatives aimed at improving compliance with regulatory requirements and standards.
Take a proactive role in process improvements, which includes the review and update of current supporting processes and procedures to enhance efficiency and effectiveness.
Achieve a difficult balance of involvement, independence, and objectivity.
Provide support for periodic review of Quality Agreements, ensuring alignment with organizational and regulatory expectations.
Collect, analyze, and report relevant metrics to inform decision-making and track the effectiveness of initiatives.
Consistently demonstrate 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.
Experience/Skills:
Bachelor’s degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
5-7 years of experience in Quality Assurance / Regulatory Affairs (Pharmaceutical or Medical Device preferred)
3-5 years of experience in clinical research and development or manufacturing, or analysis of investigational products
Minimum of 7 years’ total combined experience required (Not necessarily the sum of the above)
Must have experience with quality agreements and knowledge of worldwide regulatory requirements that influence their content.
Persuasive, effective communication skills are essential with an ability to work effectively across functions, across technical areas, and outside of the company.
Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment.
Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience
Experience Level = 5-7 Years
2nd Position : The main difference between the two is the focus: One is GCP, one is GMP/GDP.
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 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.
Qualifications :
- 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).
Job Tags
Contract work, Worldwide,