Description

You’re driven, resourceful, and above all else - remarkably smart.

In this role, your primary focus will be to conduct GxP Audits or other services such as CAPA management or other consulting activities.  You will work with some of the industries sharpest minds and will enjoy flexibility to conduct your professional Pharmaceutical and Biotech Clinical Audits as the lead and primary auditor.  To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting audits, strong GCP background, deep understanding of CRO auditing and excellent communication skills. You will:

• Schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to: investigator sites, trial master and project management files, data management activities and files, safety reporting, final study reports, and vendors.
• Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
• Expertise in management of deviations and Non-Conformities (NCs); RCA and CAPA process based on FDA, EMA, MHRA requirements specifically focused on GCP 
• Work in a defined, robust and documented end to end deviation and CAPA management process 
• Able to determine if the investigation is commensurate with the significance and risk and determine if appropriate actions have been taken and were effective (effectiveness checks for Critical NCs/ Major NCs when required) 
• Ability to plan, organize and effectively communicate with customer stakeholders in the investigation, building a rapport with the team.
• Maintain accurate and timely documentation of QA auditing activities.
• Serve as a trainer and mentor to newly hired QA Auditors.
• Maintain subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
• Participate in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.

Desired Requirements:

• Demonstrated initiative, uncompromised integrity and a results-oriented mindset
• Bachelor’s Degree in the science/health care field or equivalent combined education and experience.
• Extensive experience in clinical quality assurance auditing (GCP)and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.)
• Strong knowledge of all applicable Good Clinical Practice (GCP) regulations and guidelines.
• Good Manufacturing Practices (GMP) auditing experience, preferred
• Good Pharmacovigilance Practices (GVP) clinical safety and post-marketing auditing experience, preferred.
• Knowledge of medical terminology preferred.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Strong organizational, presentation, documentation, and interpersonal skills with diverse cultures.
• Ability to negotiate and provide constructive feedback.
• The ability to travel up to 50% (though for CAPA management and other remote activities travel is not required)

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.

Work Here Matters Everywhere | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, flexible paid time off (PTO). Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable national/federal, state, and municipal paid sick time requirements.