.Principal Prof, Clinical Quality Management Specialist - Fully remote / urgent needUpdated: October 3, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24005275Principal Professional, Quality ManagementSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.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.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 ResponsibilitiesGeneral Profile
- Provides quality support to consultancy for GCP 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 leadership.
- 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