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Princ Prof, Quality Management

vor 4 Monaten

Home Office, Schweiz Syneos Health Clinical Vollzeit

**Description**

**Principal Professional Quality Management Fixed Term - Until Oct. 1st 2023**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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
- Remote

**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).
- 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**
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Prod