Princ Prof, Quality Management

vor 2 Wochen

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 nonstandard 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 nonstandard 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 mediumscale, may lead large Quality Management projects or programs with moderate risks and resource
Supervision

  • Normally receives little instruction on daytoday work, general instructions on new assignments
Other tasks

  • Represents Quality Management, as assigned
  • Performs other qualityrelated 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 teamoriented skills.
  • Ability to act independently and proactively.
  • 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

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