Qa Auditor Iii/ Compliance Manager Milano

Qa Auditor Iii/ Compliance Manager
Milano
Lombardia, Milano

Company description**:

PPD is now part of Thermo Fisher Scientific.

As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer.

We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.

We are vital links between an idea for a new medicine and the people who need it.

We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.

You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

**The Quality Difference at Thermo Fisher Scientific**: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind.

Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world.

When you join our team of quality professionals, you'll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

**Our 4i Values**:

Integrity - Innovation - Intensity - Involvement

**Diversity Statement**:

PPD clinical research services is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect.

PPD clinical research services 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.

**Job description**:

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**:

- 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

- Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings

- Provides mentorship and guidance to junior auditors.

**Required profile**:

**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.

**What we offer**:

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, 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, 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.