Compliance Specialist (Cambridge, UK)

PPD’s mission is to improve health.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.

Currently, we are looking for aCompliance Specialistto join our team.

Main responsibilities of the role include:

· Supports and executes Compliance strategies and initiatives across PPD;

· Hosts GCP client audits in respective PPD office(s); This includes qualification audits of PPD as well as project-specific audits for Phase II-IV Services.

· Works with PPD project teams and functional departments to coordinate audit activities throughout the audit process (preparation, conduct, response, and follow-up)

· Interacts with Client Auditors and PPD representatives throughout the audit process

· Ensures all audit findings are responded to and appropriately followed up;

· Tracks client audits and findings, and maintains relevant audit documentation;

· Participates in collection and review of audit responses from client audits

· Works independently with minimal supervision or mentoring required.

· Maintains audit tools and materials

· Provides other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) Department.

PPD’s mission is to improve health.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.

Currently, we are looking for aCompliance Specialistto join our team.

Main responsibilities of the role include:

· Supports and executes Compliance strategies and initiatives across PPD;

· Hosts GCP client audits in respective PPD office(s); This includes qualification audits of PPD as well as project-specific audits for Phase II-IV Services.

· Works with PPD project teams and functional departments to coordinate audit activities throughout the audit process (preparation, conduct, response, and follow-up)

· Interacts with Client Auditors and PPD representatives throughout the audit process

· Ensures all audit findings are responded to and appropriately followed up;

· Tracks client audits and findings, and maintains relevant audit documentation;

· Participates in collection and review of audit responses from client audits

· Works independently with minimal supervision or mentoring required.

· Maintains audit tools and materials

· Provides other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) Department.

Education and Experience:

·Bachelor's degree

·3 years of clinical quality experience

Knowledge, Skills and Abilities:

·Excellent oral and written communication skills

·Solid organizational and time-management skills

·Extensive knowledge of the clinical trial process

·Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines

·Effective problem-solving skills

·Strong attention to detail

·Ability to work independently as required

·Strong computer skills; ability to learn and become proficient with appropriate software

·Able to multi-task and prioritize competing demands/work load

·Proven flexibility and adaptability

What we offer

At PPD we hire the best, develop ourselves and each other, and recognise 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 you will benefit from an award-winning learning and development programme, 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 havea flexible working culture, where PPD 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 organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

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

Education and Experience:

·Bachelor's degree

·3 years of clinical quality experience

Knowledge, Skills and Abilities:

·Excellent oral and written communication skills

·Solid organizational and time-management skills

·Extensive knowledge of the clinical trial process

·Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines

·Effective problem-solving skills

·Strong attention to detail

·Ability to work independently as required

·Strong computer skills; ability to learn and become proficient with appropriate software

·Able to multi-task and prioritize competing demands/work load

·Proven flexibility and adaptability

What we offer

At PPD we hire the best, develop ourselves and each other, and recognise 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 you will benefit from an award-winning learning and development programme, 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 havea flexible working culture, where PPD 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 organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

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