QA Release and Regulatory Senior Subject Matter Expert

Thermo Fisher Scientific Inc.; Swindon; On-site; GBP 35,000 - 55,000; Full time

Job summary

Join a leading biopharmaceutical company committed to making the world healthier and safer. In this role, you'll oversee product quality management and regulatory compliance, contributing to the manufacturing of pharmaceutical products. The position requires strong expertise and a master's degree in a relevant field, along with experience in the pharmaceutical sector.

Benefits

Competitive remuneration

Annual incentive plan bonus

Healthcare benefits

Outstanding career development prospects

Qualifications

• Minimum scientific master's degree in Pharmaceutical Science or Pharmacy required.
• Proven experience in pharmaceutical industry is essential.
• Fluency in English and French languages required.

Responsibilities

• Coordinate product quality management.
• Supervise compliance with international regulations.
• Manage regulatory compliance activities.

Skills

Quality focus

Analytical approach

Communication skills

Fluent in English and French

Proficient with MS Office Suite

Education

Master's degree in Pharmaceutical Science or Pharmacy

Tools

MS Office Suite

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This role is based in our dynamic biopharmaceutical manufacturing site in Belgium Seneffe, where we develop and produce pharmaceutical products for both clinical trials and commercial applications.

Discover Impactful Work:

Join us in ensuring flawless regulatory compliance and product quality management. Your expertise will help us deliver world-class pharmaceutical products and maintain rigorous standards.

A day in the Life:

• Coordinate product quality management

• Supervise activities ensuring compliance with international regulations

• Manage regulatory compliance activities and maintain authorizations

Keys to Success:

• Strong focus on quality with an analytical approach

• Proven ability to work independently and as part of a team

• Outstanding communication skills with clients and regulatory agencies

Education

• Minimum scientific master's degree within Pharmaceutical Science or Pharmacy (or equivalent experience) – must be eligible to apply for QP within Belgium

Experience

• Strong proven experience in the pharmaceutical industry

Knowledge, Skills, Abilities

• Expertise in EU and US GMP requirements and guidelines

• Fluent in both English and French languages

• Excellent written and oral communication skills

• Proficient with MS Office Suite (Excel/Word/PowerPoint)

Physical Requirements / Work Environment

This role involves working in a controlled manufacturing environment, adhering strictly to GMP guidelines to ensure product quality and compliance.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.