(Sr) Director, Operational Process & Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Discover Impactful Work:

We are seeking a Director/Sr Director of Operational Process & Compliance who will provide enterprise-wide strategic leadership in process optimization, governance, compliance, and risk management. Ensures business-wide adoption of process and compliance frameworks to drive efficiency, risk reduction, and regulatory excellence while overseeing SOP governance and simplification to enhance standardization, usability, and continuous improvement.

A Day in the Life:

• Partners with our Global Process Owner framework (GPOs) (divisional boards and individuals), cross functional stakeholders and divisional leadership to align on the overall strategy for process and compliance activities and ensure directives are implemented efficiently, effectively, and sustainably.
• Leads enterprise-level process and compliance initiatives, ensuring alignment with business objectives.
• Serves as a strategic advisor to executive leadership on risk management and process optimization.
• Leads a team of direct report and matrixed colleagues.
• Develops and implements enterprise-wide frameworks for risk surveillance and compliance monitoring.
• Oversees governance committees, process improvement projects, and compliance initiatives.
• May serve in a leadership role as an executive sponsor or member on initiatives, boards or committees.
• Directs the framework to enable the organization to execute proactive risk identification and mitigation strategies to enhance regulatory compliance.
• Mentors senior leadership and fosters a culture of continuous process and quality improvement.
• Creates formal networks internally and externally with key decision makers.

Keys to Success

Education:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
• 7+ years of management responsibility

Knowledge, Skills and Abilities:

• Outstanding leadership and management skills
• Advanced skill in process development and improvement, especially as it applies to clinical trials and clinical development
• Superior attention to detail, investigative and analytical skills
• Outstanding interpersonal, negotiation and problem-solving skills
• Superior computer skills, to include an effective understanding of clinical management technology and systems
• Expert understanding of the practices, processes and requirements of clinical trials, to include regulatory guidelines and directives
• Superior oral and written communication skills including the ability to communicate in English, both orally and in writing
• Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
• Capable of driving innovation in developing new ideas related to process improvements
• Outstanding organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, frequent travels both domestic and international.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects