Job Description

Work Schedule

Environmental Conditions

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information:

This role is a member of the Quality Assurance Team in the Customer Channels Group (CCG) supporting current business needs and the growth to enable GDP capabilities at Independence.

Onsite position at Pittsburgh, PA office

Discover Impactful Work:

The Quality Agreement Specialist is responsible for developing, negotiating, and leading quality agreements with customers, external partners and suppliers. This role ensures that all quality standards and regulatory requirements are met, fostering strong relationships and maintaining compliance across all quality-related activities.

A day in the Life:

1. Quality Agreement Development:

• Draft, review, and negotiate quality agreements with external partners and suppliers.
• Ensure agreements align with regulatory requirements and company standards.
• Collaborate with legal, procurement, and other relevant departments to finalize agreements.

2. Compliance and Regulatory Oversight:

• Monitor compliance with quality agreements and regulatory standards.
• Conduct regular audits and assessments of external partners to ensure adherence to quality agreements.
• Stay updated on relevant regulations and industry standards.

3. Relationship and Process Management:

• Build and maintain strong relationships with external partners and suppliers.
• Serve as the primary point of contact for quality-related issues with external partners.
• Facilitate communication and resolution of quality-related concerns.
• Coordinate with internal functional departments to ensure various site startup activities align with department priorities and contractual activities within mutually agreed-upon timelines.

4. Documentation and Reporting:

• Maintain accurate and up-to-date records of all quality agreements.
• Prepare reports on compliance status, audit findings, and corrective actions.
• Ensure proper documentation of quality-related activities and communications.

5. Continuous Improvement:

• Drive opportunities for process improvements in quality agreement management.
• Provide training and guidance to internal teams on quality agreement processes.

Keys to Success:

Education

• Bachelor’s degree in Quality Assurance, Life Sciences, Engineering, Business Administration or related field.

Experience

• Minimum of 3+ years of experience in quality assurance or regulatory affairs, preferably in the pharmaceutical, biotechnology, or medical device industry.

Knowledge, Skills, Abilities

• Strong knowledge of regulatory requirements (e.g., FDA, EMA, ISO standards).
• Effective communication skills (verbal & written) in English
• Basic knowledge of agreement/contracting processes is a must.
• Excellent negotiation, communication, and interpersonal skills.
• Detail-oriented with strong organizational and documentation skills.
• Ability to work independently and handle multiple projects simultaneously.
• Excellent problem solving, risk assessment and impact analysis abilities
• Flexible and able to multi-task and prioritize competing demands/resolve complex issues

Preferred Qualifications:

• Certification in Quality Management (e.g., ASQ, Six Sigma).
• Experience with leading negotiations and actively participating with the agreement/contracting processes.
• Mastery ability to effectively and efficiently escalate out of parameter issues and offer resolution suggestions
• Demonstrated ability to effectively negotiate contracts in the best interests and position of the company.

Physical Requirements / Work Environment

• Office environment with occasional travel to partner and supplier sites.
• Full-time position with standard working hours; some flexibility may be required.

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!

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