Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Location/Division Specific Information

As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization.

How Will You Make an Impact

The Director, Steriles Manufacturing Quality Assurance will provide quality oversight to manufacturing operations ensuring full compliance of quality, customer, and regulatory requirements for multiple filling lines, visual inspection, and packaging. Driving best-in-industry as it relates to continuous improvement by growing quality, compliance and efficiency standards. This role specifically includes providing comprehensive quality oversight for customers with high value products. As a member of the Quality Management Team, this role advises on quality and regulatory issues.

A Day in the Life:

Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement by role modeling the values.Responsible for Steriles product quality, compliance, conformance to quality requirements and specifications, and conformance to customer quality requirements. Leads multiple functional work teams such as quality on the floor, batch release, customer support, and matrix structure for sterility assurance.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 Steriles Manufacturing Quality Assurance to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way. Advise quality top management on issues that may affect the site and/or Thermo Fisher Scientific as a whole.Represent Steriles Manufacturing Quality Assurance in all Regulatory and Customer Inspections as well as compliance issues.Ensure efficient operations to support commitments to customers regarding product delivery and project results.Represent Steriles Manufacturing Quality Assurance on Quality Governance committees.Ensure adherence of Manufacturing and Packaging to all relevant worldwide regulatory requirements. Provide systems to maintain compliance with these requirements.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.

Education

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

Experience

15+ years of cGMP experience in the pharmaceutical industry with at least 8 years of steriles manufacturing experience required.10+ years in a leadership role, committed to employee engagement and development required.

Knowledge, Skills, and Abilities

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.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

What We Offer

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!