Quality Assurance Auditor (All Levels)/ Compliance Manager

PPD Czech Republic, s.r.o.

Place of work
Remote work
Contract type
full-time

Information about the position

Job description, responsibilities and duties

As QA Auditor III/Compliance Manager within the Quality Investigation and Support team, you will be involved in multiple aspects of quality assurance.

Summarized Purpose:

Provides guidance to operational departments as a subject matter expert (SME) for regulations, ICH GCP guidance, and PPD SOPs. Provides support to clients and internal teams for regulatory inspections of sponsors and investigator sites. Leads/coordinates investigation of suspected scientific misconduct cases. May perform directed audits and provide audit reports to management. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.

Essential Functions:   

- Provides GCP consultation and support to PPD project teams and external clients
- Provides support to clients and internal teams for regulatory inspections of sponsors and investigator sites
- Leads/coordinates investigation of suspected scientific misconduct cases including conduct of directed audits
- Serves as a resource to operational departments on audit or quality assurance subject matter
- Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
- Provides mentorship and guidance to junior auditors

Education and Experience: 

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:   

- Thorough knowledge of GxP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
- Excellent oral and written communication skills
- Strong problem solving, critical thinking, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Above average negotiation and conflict management skills
- Flexible and able to multi-task and prioritize competing demands/workload

Employee perks, benefits

PPD Defining Principles: 

We have a strong will to win - We earn our customer’s trust - We are game changers - 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.  

Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)

Language skills

English - Upper intermediate (B2)

Advertiser

Brief description of the company

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Number of employees

1000 and more employees
ID: 4178265  Datum zveřejnění: 10.11.2021