Quality Specialist II

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Due to a growing portfolio, we are currently looking for a Quality Specialist to be based in the UK with flexible working hours.

Your time here

At Parexel, ourAudit Specialist have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections.

Key Accountabilities:End-to-End Facilitation of Sponsor Audits

- Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, throughout the lifecycle of an Audit- Conduct all preparation meetings, assign tasks with other internal departments and gather necessary information on Sponsor confidentiality agreement documentation.- Initiate planning process(es), e.g., project plans with deadlines and milestones, to administer an audit effectively and seamlessly- Ensure audits are performed to a high degree of client satisfaction

- Build, develop, and maintain good working relationships with internal and external customer groups- Determine most appropriate setting to host an audit, based upon sponsor audit requirements- Actively support audit host throughout a sponsor audit onsite (where applicable)- Support Non-Parexel-facility audits, e.g. supplier sites, internal audits at sponsor offices, as applicable- Ensure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirements

Support the maintenance of sponsor audit and inspections Tools:

- Summarize quality issues arising from sponsor audits and other related activities, as requested.- Enter Sponsor audit information into the Parexel audit module of eQMS and provide follow up on outcomes, as needed.- With First Time Quality – ensure that information is added and relayed effectively and correctly

Maintain GXP and Regulatory Awareness:

- Maintain relevant knowledge of appropriate GxP requirements and developments as they impactParexel’s international SOPs and compliance with GxP. Communicate to QA team and management, as applicable- Promote compliance within the company and represent QA, as required- Proactively re/review QA SOPs and be able to speak to their contents- Develop and maintain network contacts with other Quality Assurance professionals- Support regulatory inspections as needed

Build and Maintain Relationships:

- Build, develop, and maintain good working relationships with internal and external customer groups.- Work well in team environment.

Perform other quality related tasks or projects as assigned:

- Perform other quality related tasks or duties as assigned.- Travel on assignments as required. Travel time could be up to 20%.

Skills: Ability to confidently and diplomatically address sensitive issues professionally Excellent interpersonal, verbal and written communication skills Ability to manage multiple and varied tasks with enthusiasm and prioritize workload withattention to detail Experience with Microsoft based applications and ability to learn internal computer systems Willingness to work effectively with multiple supervisors in a matrix environment and to valuethe importance of teamwork Ability to develop relationships with culturally diverse stakeholders, including Parexel teammembers and sponsor representatives Ability to work professionally with highly confidentialinformation Flexibility and ability to adjust to changing priorities and unforeseen events Excellent time management skills and the ability to follow-up on multiple tasks and projects Ability to diplomatically address sensitive issues confidentially and professionally A team player with a positive attitude Ability to work consistently in a fast-paced environment

Knowledge and Experience: Significant experience in Quality Assurance, auditing, relevant Quality Management andclinical trial support Strong knowledge of GxP, industry standards, applicable regional regulations Must be detail oriented and able to maintain a ‘big picture’ overview during a sponsor audit orinspection Ability to follow up on multiple tasks and projects, and to handle confidential informationdiplomatically

 MS Office standard application skills required (MS Teams, Word, Excel, Outlook)

Education: Educated to degree level (technology, biological science, pharmacy or other health relateddiscipline preferred) or equivalent qualification or clinical research experience Strong command of written and spoken English language, local language proficiency asrequired

Note:

Pharmacovigilance background preferred for this req.

A little about us:Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away.

Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees