Sr Director Digital System Quality Assurance

1 week ago

Cambridge, United States Thermo Fisher Scientific Full time

Work Schedule

Other

Environmental Conditions

Office

Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

This Senior Director of Digital System Quality Assurance, Global Quality Systems, role is a remote position in our Global Quality Systems team within the Pharma Services Group.

How will you make an impact?

You will create, lead, and implement a strategic plan for PSG global digital Quality Assurance systems. Your role will include strategic direction for digital systems, data analysis, AI, digital dashboards, metrics, and GMP computer system compliance for quality operations. Your role will be to ensure PSG has the appropriate policies, procedures, and operational practices to maintain computer system compliance with appropriate FDA and EMEA requirements. You will provide leadership for data analysis, AI, metrics, and real-time reporting for overall PSG quality performance. You will direct a team of staff to provide Quality Assurance oversight of Computer System Validation as well as system administration where quality is the business owner.

What will you do:

Provide leadership and expertise in the interpretation, development, and implementation of global policies to ensure initial and on-going compliance of digital systems with cGMP, 21 CFR Part 11, Annex 11, and GAMP requirements.

Provide strategic direction for AI, quality metrics, reporting, and quality dashboards resulting in real-time assessment of quality performance.

Direct teams to provide quality assurance leadership for PSG wide Pharma 4.0 / Digital Lighthouse /AI efforts to implement digital manufacturing execution systems, laboratory information systems, and the ability to use multiple data platforms for information consolidation.

You will work within the PPI framework to instill a continuous improvement mentality for all projects within your department.

You will ensure establishment of metrics to monitor the on-going health of the digital compliance at the sites.

Collaborate with Thermo Fisher corporate functions, e.g. Enterprise Technical Operations (ETO), QARC-IT, PSG-IT, etc. to ensure continuous and verifiable compliance throughout the entire GMP digital environment and lifecycle.

You will represent Quality on key digital system initiatives for PSG and broader Thermo Fisher.

You will have direct reports and/or some matrixed staff who will be providing Quality Assurance oversight of CSV projects, implementing PSG quality metrics, and quality digital system administration. You will be responsible for the management and development of staff reporting to you.

You will direct staff to engage with digital improvement efforts, e.g. AI, Digital Lighthouse, Pharma 4.0, to improve the digital performance of our sites, increasing customer satisfaction, gaining efficiency, and improving compliance.

Additional Duties and Responsibilities

Subject Matter Expert on pharmaceutical computer system validation requirements, processes, and tools.

Ability to influence global and site leadership to pilot and implement new computer systems.

Ability to lead and develop staff at the specialist, manager, senior manager, and director level. Ability to achieve work output through other directors and managers.

Visibility and participation in external professional organizations to ensure comparison with external benchmarks and opportunity to influence regulatory environment.

Strong organizational skills; ability to prioritize and manage through complex processes/projects; manage and prioritize team work contributions as well.

Ability to effectively present information to employees, top management, public groups and/or boards of directors.

How will you get here:

Education

BS in a scientific/technical subject area. Graduate degree preferred.

Experience

10+ years of experience in a quality leadership position, or >15 years progressive management experience with GMP responsibilities within the pharmaceutical or medical device (regulated) industry.

Significant experience in computer system validation in the pharmaceutical/medical device environment including authoring validation documents and active participation/leadership on computer validation teams.

Project/Program Management skills and demonstrated leadership.

Experience in pharmaceutical development and/or manufacturing.

Knowledge, Skills, Abilities

Excellent oral and written communication skills. Excellent internal and external presentation skills.

Ability to multitask, strategically and tactically

Solid knowledge of FDA and EMA regulatory requirements applicable to digital computer systems in pharmaceutical development and manufacturing.

Ability to interpret and apply GAMP regulations and international guidelines to all aspects of the position

Ability to collaborate with different group and corporate teams.

Other Job Requirements:

Ability to function in a constantly evolving environment and balance multiple priorities simultaneously.

Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing writing.

Some domestic and international travel required (up to 20% for one to two weeks at a time).

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

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

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.

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