Job Details

ID #44679848
State South Carolina
City Greenville / upstate
Full-time
Salary USD TBD TBD
Source Thermo Fisher Scientific
Showed 2022-08-07
Date 2022-08-07
Deadline 2022-10-06
Category Et cetera
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Director, Manufacturing Quality Assurance-Steriles

South Carolina, Greenville / upstate, 29601 Greenville / upstate USA

Vacancy expired!

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .Group/division summaryThe Pharma Services Group (PSG) is transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes. This role will lead all aspects of Quality Assurance at our Growing Greenville, NC facilityPOSITION SUMMARY:The Director, Manufacturing Quality Assurance will provide quality oversight to manufacturing operations ensuring no harm is done to the patients. 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.Key Responsibilities:Set strategy and direction for handling key customer relationships; including proactive risk mitigation, right first time, regulatory trends, etc.

Attracts, develops and retains top talent to build an outstanding quality organization.

Designing flexible quality systems to be able to incorporate current/future customer quality requirements.

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

Set strategy and direction for 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 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 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.

Lead and develop employees in order to realize safety, Quality and business goals. This will include expertise is designing, training and implementing root cause analysis tools.

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.

A minimum of 10 years of GMP experience in the pharmaceutical industry with at least 5 years of steriles experience.

A minimum of 8 years in a leadership role, committed to employee engagement and development.

Deep knowledge of cGMPs and pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs.

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

Strong communication, persuasion, and presentation skills.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.

Vacancy expired!

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