Principal, (Gvp) Quality Management - Uk Based Role

5 months ago

Remote, United Kingdom Syneos Health Clinical Full time

**Description**

**Principal Professional Quality Management**

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**

Functional Quality Representative role provides end-to-end GVP quality oversight for activities performed within the Research and Development (R&D) division, including post-marketing pharmacovigilance and regulatory life-cycle management activities.

With a strong background in and understanding of GVP, you will join a small and highly motivated team as a key contributor to process development; quality oversight of all aspects of biosimilar R&D; support vendor qualifications; quality issue and CAPA management and proactive audit and inspection readiness and management.

You will drive a culture of quality and will serve as an advocate for the Quality Management System (QMS). You will act as a Functional Quality Representative (FQR), liaising with the other FQRs across the business and operate within the defined quality governance structure.
- Assures internal and external (vendors/partners) adherence to GVP and applicable regulations.
- Participates in process development, improvement and functional initiatives.
- Participates in vendor selection, qualification and oversight.
- Partners with R&D Audit to support, prepare for and facilitate internal process and vendor audits, with oversight of audit findings and CAPA implementation.
- Supports regulatory inspection readiness teams, preparations, inspection conduct and leads the development of responses to inspection findings.
- Provides risk-based GVP consultative support to post approval GVP process owners, stakeholders and governance committees.
- Identifies process and functional quality risks and forms mitigation strategies; leads investigation strategy for identified quality issues; reviews and approves SOP deviations, CAPAs and effectiveness checks; determines requirements for escalation to senior leadership and function based quality leads.
- May support other GxP activities and priorities, in particular GCP support of pre-approval biosimilar clinical development teams.

LI-NC1

**Qualifications**

**What we’re looking for**
5-7 years’ GCP experience, with a deep understanding of quality assurance, management and oversight; experience in clinical QA auditing or functional quality management preferred. In depth understanding of GVP and GCP, global regulations and standards that govern the development of clinical products; Experience with quality issue and CAPA management, including ability to identify and investigate issues, and drive effective corrective and preventative action (CAPA) plans.
- In depth understanding of GVP and GCP, global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives/Regulations, as examples)
- Experience with quality issue and CAPA management, including ability to identify and investigate issues, and drive effective corrective and preventative action (CAPA) plans.
- Experience with regulatory GxP inspection preparation, management and/or response.
- Understanding of quality by design, risk assessments and quality metrics.
- Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
- Strong understanding of drug

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