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Remote

Quality CAPA Lead

Syneos Health/ inVentiv Health Commercial LLC
United States
July 02, 2022
Description

Principal Professional Quality Management

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.

As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health

* #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.

* We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.

* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

General Profile

* Provides quality support to consultancy for GXP and related topics (moderately complex) to project teams and departments, as assigned

* Performs complex analyses to evaluate the state of the quality of a project team or department using key quality metrics and/or key performance indicators

* Investigates quality trends, potential risks and mitigations with Quality Management leadersip

* Presents information to Quality Management leadership, as applicable

Functional and Technical Expertise

* Works within a specific knowledge area. May work outside area.

* Ensures commitments and timelines for assigned activities adhere to Syneos Health requirements.

* Offers solutions to process and quality related issues and identifies process improvement opportunities

* Advises Quality Assurance (QA) auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.

* Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.

Complexity

* Solves complex problems and/or conducts complex analyses. Translates concepts into practice.

* Decision Making - Makes decisions that impact a range of standard and non-standard operational, process, project or service activities

* Influence - Serves as a key resource within a business area or discipline. Gains support for ideas or positions on difficult issues

* Problem Solving - Anticipates and resolves complex problems. Applies strategic and critical thinking to identify solutions to non-standard requests and moderately complex problems

* Impact - Drives solutions for products, processes, and services across a large business area

* Customer/External Focus - Establishes key relationships with those outside of business area. Assesses and interprets customer's (internal and external) quality needs and requirements and proactively develops solutions

* Project Management - Leads medium-scale, may lead large Quality Management projects or programs with moderate risks and resource

Supervision

* Normally receives little instruction on day-to-day work, general instructions on new assignments

Other tasks

* Represents Quality Management, as assigned

* Performs other quality-related activities as directed by management

* This position is not responsible for supervising employees

* Travel may be required (approximately 15%)


Qualifications

What we're looking for

* BA/BS degree in science or health care or equivalent education and experience, plus moderate experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP).

* Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail.

* Above average attention to detail and accuracy.

* Strong organizational, interpersonal and team-oriented skills.

* Ability to act independently and pro-actively.

* Significant project management and customer management skills.

* Ability to perform several tasks simultaneously to meet deadlines.

Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#LI-HA1


Primary Location : Europe - FRA-Home-Based
Job : Quality
Schedule : Full-time
Travel : No
Employee Status : Regular

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