Job Description

PPD clinical research services’s mission is to improve health (https://www.ppdi.com/about/purpose-mission-strategy) . It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams (https://www.ppdi.com/careers/about/culture) .

The AD, Regulatory Inspections will act as a pro-active QA support and oversight function to clinical, project delivery and functional areas on executing real time inspection readiness and preparation activities for global studies/clients. Additionally, the role will coordinate and support inspection management activities for global health authority inspections of PPD.

Key Responsibilities:

• Interact with cross functional team members and study teams from several therapeutic areas and clients in planning and execution of Inspection readiness activities

• Support manager and others within Regulatory Inspection and Client Audits (RICA) department to host and/or coordination of HA Inspections at PPD and all related activities

• Assist manager in planning and conduct of Mock Inspections as assigned

• Pull, analyze and maintain related inspection metrics and trends; support manager in managing the status of positive areas and those showing improvements required

• Support the clinical and other functional areas in risk assessment activities pertaining to study, site or process to identify areas of increased risk to internal processes.

• Evaluate signals and trends from Root Causes and ensure the commitments with HA are fully tracked by the actioned owners.

• Support billable QA Inspection preparation models as contracted by clients.

• Review or assist manager on the review of findings responses (CAPA) to HA Inspections for adequacy to address non-compliance and minimize risks to business.

Education And Experience:

• Bachelor's degree required.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.

• Previous people or project management responsibility preferred

• 5+ years of previous experience in supporting or participating in FDA or other Health Authorities (HA) related GCP or Pharmacovigilance inspections

• Previous experience in clinical QA or clinical compliance related functions desired

• Strong experience in GCP

Knowledge, Skills And Abilities:

• Solid drug development and quality management related knowledge

• Demonstrated ability to collaborate and align QA with clinical operations and other functional areas

• Great oral and written communication skills

• Strong problem solving, risk assessment and impact analysis abilities

• Solid experience in root cause analysis

• Solid experience in CAPA review

• Demonstrated experience in process improvement

• Strong negotiation and conflict management skills

• Familiar with QA information management systems

• Flexible and able to multi-task and prioritize competing demands/work load

• Ability to think independently and influence when appropriate

• Solid knowledge of FDA/Competent Authority inspection methodologies, FDA risk assessments, non-conformance interpretation/management, regulatory reporting requirements, and regulatory enforcement activities.

• Work may involve travel within the USA and other countries to attend HA inspections

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme (https://www.ppdi.com/careers/about#Training) , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture (https://www.ppdi.com/careers/life-at-ppd) , where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.