Sr. Manager (Site Quality Head)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Group/Division Summary

Within our Clinical Trials Division (CTD) we collaborate globally with pharmaceutical and biotech clients to deliver precise reliable solutions that advance patient care.

Discover Impactful Work:

We are seeking a seasoned Quality Leader to lead all aspects of the Quality operations at our Mount Prospect IL location. This individual will be accountable for all aspects of the sites Quality organization including clinical packaging labeling and distribution operations. The Site Quality Head ensures that quality systems are successfully implemented regulatory expectations are consistently met and business goals are achieved. This role is both strategic and hands-on providing leadership across compliance inspection readiness continuous improvement and client partnership.

A Day in the Life:

Leadership & Strategy

• Establish and lead short- and long-term Quality objectives aligned with company goals PSG & CTD strategy and site priorities.

• Serve as a member of the site leadership team actively shaping business strategy while ensuring compliance is never compromised.

• Provide mentorship coaching and development opportunities to cultivate a hard-working Quality organization.

Quality Compliance & Regulatory Oversight

• Manage and elevate the site Quality System to align with cGMP FDA EMA and global regulatory standards ensuring adherence throughout all packaging labeling and distribution procedures.

• Oversee qualification validation and equipment/premises maintenance while driving a proactive culture of inspection readiness.

• Act as the primary Quality representative during health authority and client inspections mitigating risks and ensuring successful outcomes.

• Ensure each batch of medicinal product meets applicable legal and regulatory requirements while maintaining transparency with leadership and clients.

Operational Excellence & Customer Focus

• Partner with Operations Supply Chain and Client Services to deliver reliable Right-First-Time execution of packaging and distribution activities.

• Drive a culture of proactive compliance accountability and continuous improvement.

• Support business development activities by positioning Quality as a differentiator in client engagements and proposals.

Keys to Success:

Education

• Bachelors degree in a scientific or technical field (advanced degree preferred).

Experience

• At least 7-8 years of dynamic Quality leadership experience in the pharmaceutical or medical device industry including contract manufacturing packaging or distribution is required.

• Regulatory Expertise: Extensive understanding of cGMP FDA EMA and other global regulatory requirements with a track record of effectively coordinating inspections and ensuring compliance.

• Leadership & Influence: 3- 5 years of leadership experience (required) with validated capability in guiding and encouraging dedicated teams collaborating effectively with diverse partners and portraying Quality Unit as a dependable partner to clients and regulators.

Physical Requirements:

• Ability to work in an office and manufacturing environment.

• Occasional travel may be required.

Benefits

We offer competitive remuneration annual incentive plan bonus scheme 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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager