Senior Advisor, Quality Assurance

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Job Introduction

Position: Senior Advisor, Quality Assurance

Location: Rushden

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to biologics and gene therapies, and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.

About the Role

We are looking for a Senior Advisor, Quality Assurance (QA) to join our QA team at our Rushden site. In this role you will be responsible for monitoring the status and reporting of studies and other programmes, ensuring compliance with the appropriate Good Laboratory Practice (GLP)/ Good Clinical Practice ((GCP) - sample analysis only) regulations and requirements. This is an onsite, full time role but we can offer flexible start and finish times.

Key Responsibilities

• To assure that regulatory studies are performed in compliance with the appropriate GLP/ GCP regulations
• To conduct timely and effective GLP/ GCP Inspections according to authorised documents/ Company Standard Operating Procedures (SOPs) and as directed by the Line Manager
• To conduct accurate and timely audits of draft Reports (including more complex areas) according to company SOPs and as directed by the Line Manager
• To perform Final Report/ Report Amendment audits and subsequent sign-off
• To perform Process, System and Facility inspections to determine that Plans and SOPs are being followed
• To promptly report findings following audits and inspections to the Scientific Staff and Management
• To investigate deviations from Plans or SOPs (including the review of any corrective and preventative actions required) and to advise Scientific Staff and Management accordingly
• To demonstrate an understanding of the requirements and expectations of GLP/ GCP principles and pragmatically apply them in discussions in order that consistent guidance and advice can be provided to staff as appropriate
• To resolve with Scientific Staff as necessary, apparent inaccuracies and irregularities, arising out of observations made during inspection/ audit
• To support continuous Quality improvement and advise Scientific Staff and Management accordingly
• To write, review and authorise SOPs and Policies
• To assist with the training of junior members of the QA team and other members of staff within the company where required
• To act as a mentor to more junior members of the QA team

Candidate Profile

• Relevant auditing experience within a CRO/ Pharmaceutical environment
• Experience of GLP/ GCP compliance with a good knowledge of current GLP/ GCP guidelines and industry trends regarding data integrity
• Excellent attention to detail with an enquiring mind
• Good communication skills with the ability to communicate effectively at all levels within a large organization.
• Strong interpersonal and relationship-building skills with the ability to influence and encourage a quality mindset
• Excellent planning and organization skills - ability to multi-task, manage time and accept changing priorities.
• Ability to work within and effectively contribute to multidisciplinary scientific teams and environments
• Strong IT Skills with a good working knowledge of MS office

Why Pharmaron?

Collaborative Culture: Thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.