You are a seasoned Quality Assurance Professional with life science experience which allows you to provide advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services environment.

Are you passionate about building a harmonized, world-class quality unit facilitating change aimed at positively impacting the systems and culture? Are you always looking for ways to improve policies, procedures and processes? Are you capturing and interpreting data, spotting trends and influencing continuous improvement? Does training and education energize you?

What Your Day to Day Will Look Like:

• Designing, implementing, optimizing and maintaining operational and quality policies and procedures, ensuring compliance with all applicable regulations, guidance, and standards, while ensuring business processes are designed to maximize value for internal and external clients.
• Collecting and monitoring performance metrics, including identification of trends that require preventive action and recommend remediation and improvements.
• Monitoring daily work operations and providing direction and guidance to staff to achieve unit or project goals. Responding to requests and explaining procedures to internal and external clients, by interacting and meeting regularly.
• Actively participating in implementations, serving as site head of Quality.
• Designing, planning and delivering interactive presentations on cGxP topics, industry/site trends, and business tools/practices and monitoring training effectiveness.
• Hosting and conducting audits.

About Us:

Precision for Medicine develops assays and runs global logistics for Clinical Trials by using biomarkers to stratify patients, incomparably improving R&D efficiency and success for our clients. We lead every aspect of clinical trials from sites to biomarkers to diagnostics, dramatically accelerate our clients pathway from proof of concept to drug approval.

Our specialty in vitro and ex vivo assays achieve a variety of research, safety, efficacy, and biomarker objectives to speed and streamline research and clinical trials. Multiplatform immune monitoring solutions support our clients from preclinical through phase 3 studies, supported by our global biorepository footprint, cell biology, sample processing, and molecular capabilities. Because our clients need high-quality, accurate study results, we deliver meticulous sample handling and sophisticated global logistics—always utilizing industry-leading quality systems, including GxP, GLP, ISO 13485, College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA).

Qualifications:

Minimum Required:

• Bachelor’s Degree or equivalent
• 8 years’ experience working in a Quality function related to Pharmaceutical/Life Sciences-Regulated environment

Other Required:

• Pharmaceutical QA and or operations experiences
• Demonstrated highly developed skills; communication, including well-developed writing, verbal and interpersonal skills
• Working knowledge of worldwide industry standard methodology, guidance, and regulations, including GLP, CLIA, and ICH
• Well-developed leadership skills
• Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
• Experience in interpreting and analyzing data
• Experience working with Regulatory Agencies and Notified Bodies
• Successful history accomplishing tasks on time and performing administrative functions
• Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function independently within a minimally supervised environment with exceptional attention to detail required
• Able to travel approximately 30%-40% both domestically and internationally including overnight stays
• Possess a valid driver’s license allowing you to drive in the state(s) you drive in
• Able to read, write, speak, fluently and comprehend the English language

Preferred:

• Master’s Degree in Regulatory Science
• Professional Quality Certification, preferably in Auditing or Continuous Improvement