Director, Quality Assurance – Batch Release & Customer Relationship

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

As part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

POSITION SUMMARY

The Director, Quality Assurance – Batch Release & Customer Relationship provides strategic quality oversight of customer support functions , with a primary focus on batch record review and release to ensure full compliance with internal standards, customer expectations, and regulatory requirements across multiple business units. This role drives excellence in right-first-time batch disposition by partnering with internal stakeholders to drive key cycle time metrics, strengthening review processes, improving documentation accuracy, and advancing continuous improvement initiatives that enhance quality, compliance, and efficiency.

Additionally, this position serves as a key quality liaison for customers, providing dedicated oversight for high-value products and fostering strong, transparent relationships. The Director partners closely with customers to address quality concerns, support audits and inspections, and ensure alignment on quality expectations. As a member of the Quality Management Team, this role provides expert guidance on quality and regulatory matters, with a strong emphasis on customer advocacy and compliance excellence.

 

Key Responsibilities:

·       Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement by role modeling the values.

·       Responsible for batch release and customer support processes to ensure compliance with quality requirements, specifications, and customer expectations. Leads multiple functional work teams including batch release, and customer support.

·       Contribute to establishment and delivery of site quality metrics, financial performance metrics and customer scorecard and satisfaction metrics.

·       Set strategy and direction for handling key customer relationships; including proactive risk mitigation, right first time, regulatory trends, etc.

·       Collaborating with industry-driving customers to design and recommend a proactive approach to meeting future industry and regulatory needs.

·       Set strategy and direction for batch record review and quality customer support. Advise quality top management on issues that may affect the site and/or Thermo Fisher Scientific as a whole.

·       Support Regulatory and Customer Inspections as well as compliance issues.

·       Ensure efficient operations to support commitments to customers regarding product delivery and project results.

·       Represent Quality Assurance on Quality Governance committees.

·       Remain current in relevant worldwide regulations pertaining to manufacturing quality assurance. This includes working with key customers to recognize future customer and regulatory expectations.

·       Develop technical, supervisory and managerial staff to improve personal and site performance. Build developmental plans for high potential staff.

·       Work closely with operations business segment leadership to establish and promote good manufacturing practices and improve quality culture.

·       Interact, negotiate and persuade management within different organizations, including internal organizations, customers and other external entities. The job holder must effectively blend the compliance of corporate quality standards with the quality requirements of customers.

 

Qualifications:

 

·       Bachelor’s degree in Physical Sciences, Engineering or related field required.

·       10+ years of cGMP experience in the pharmaceutical industry with at least 5 years of steriles manufacturing experience required.

·       8+ years in a leadership role, committed to employee engagement and development required.

·       Experience in CDMO/pharmaceutical contract manufacturing environment preferred

·       Strong demonstration of leadership capabilities required, with experience in influencing at distance and driving organization and process change. Experience in leading a compliance turnaround program preferred.

·       Advanced cGMP experience required.

·       In depth knowledge of pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs.

·       Must be able to interact with and influence the most senior levels of the organization.

·       Advanced problem-solving skills and comfortable working directly with our valued customers to determine solutions.

·       Strong communication, persuasion, and presentation skills.

·       Advanced change management skills are vital.

·       Experienced in direct, professional interactions with customers and internal business partners.

·       Ability to achieve results in a matrixed organization, using representatives from different cultures and embracing diversity.