CMC Project Manager- FSP

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

This a client dedicated role.

Role

We are seeking a highly skilled and experienced Project Manager to oversee and manage the change control system within our client's company. This role is critical in ensuring compliance with CMC regulatory requirements, maintaining product quality, and facilitating efficient project execution. The ideal candidate will have a strong background in regulatory affairs, project management, and a thorough understanding of CMC requirements in the biopharmaceutical industry.

Responsibilities

• Participate in the development, implementation and maintenance of an effective change control system for CMC-related changes;
• Coordinate and document CMC changes, ensuring compliance with regulatory and quality requirements;
• Support cross-functional team to plan, execute and close CMC-related lifecycle management projects, facilitate communication between different stakeholders to ensure smooth execution of change controls;
• Develop project plans, track progress, identify potential risks associated with regulatory changes and develop mitigation strategies;
• Facilitate project meetings, communicate project status and resolve issues promptly;
• Review and approve change control documentation, ensuring accuracy and completeness, maintain comprehensive records of CMC lifecycle management activities
• Prepare regular reports on change control status, metrics and project progress for stakeholders, incl management, internal project teams and external partners
• Identify opportunities for process improvements in change control and project management.
• Implement best practices and standard operating procedures (SOPs) to enhance efficiency and compliance.
• Train and mentor staff on change control processes and regulatory requirements.

Qualifications

• Education :
• Bachelor or Master degree in Life Sciences, Pharmacy, Chemistry, or a related field. Advanced degree preferred.
• Experience :
• Minimum of 5 years of experience in the biopharmaceutical industry, with at least 3 years in a regulatory affairs or CMC role.
• Proven experience in managing change control systems and CMC regulatory submissions.
• Strong project management skills with a track record of leading successful projects.
• Knowledge and Skills :
• In-depth knowledge of CMC regulatory requirements and guidelines (FDA, EMA, ICH).
• Excellent organizational, analytical, and problem-solving skills.
• Proficiency in project management tools and software.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Attention to detail and a commitment to maintaining high-quality standards.

What we offer :

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! 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.

Seniority level

• Seniority level Not Applicable

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance, Product Management, and Engineering
• Industries Pharmaceutical Manufacturing and Biotechnology Research

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