Thermo Fisher Scientific
Sr Manager, Quality
Thermo Fisher Scientific, Swedesboro, New Jersey, us, 08085
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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
Located at the Swedesboro, NJ site and supporting the Clinical Trials Division (CTD).
Discover Impactful Work:
Within the Clinical Trials Division, we provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the patient. The Senior Quality Manager will develop, implement and maintain the activities of the Quality function and lead colleagues across the global business reporting to them. In addition, they will help establish, maintain, and strengthen the Quality Assurance and Quality Control processes to ensure compliance of product and systems to customer and regulatory requirements.
A Day in the Life:
Promote and facilitate a safe work environment for all employees and take appropriate action to correct unsafe acts and procedures
Strengthen and improve the Quality Management System by coordinating various areas, such as Distribution Quality Assurance, auditing, document management, and CAPA resolution throughout the organization.
Be a cross functional global leader providing expertise and direction to the wider organization related to logistics.
Lead the operational quality function for the Clinical Ancillary business in North America including support for procurement, kitting and distribution.
Responsible for quality oversight and leadership for the Transportation and Logistics functions within the Pharma Services Group, including but not limited to:
Third party distribution depot/subcontractors
Courier and transportation services
Shipping validation services
Provide strategic insight and develop solutions for the logistics business to improve existing services and expand to new markets. This includes; cold chain shipping and specialization making Thermo Fisher a market leader
Cultivate a partnership with Operations to drive a culture of continuous development of quality processes
Apply a "Decision-making" approach to Quality issues that will lead to a well-rounded Root Cause and Corrective Action.
Look to improve the Distribution Quality function, including a focus on reducing customer complaints.
Define metrics that matter for quality and the operational teams.
Deliver mentorship for product-related investigations, deviations, change controls, and validation reports.
Serve as the main contact for any significant quality issues and advise the Sr Director, Quality and General Manager for the business.
Participate, lead, and drive Continuous Improvement – PPI (Practical Process Improvement) events by encouraging employees to enter JDIs (Just Do Its) and perform Gemba’s
Partners across departments and sites to ensure resolution of non-compliance occurrences
Work as a leader, provide, assistance, and support the Quality team for the overall quality management
Other duties as assigned including special projects relevant with skills and experience.
Keys to Success:
Education
Bachelor’s Degree in a science related field, Master’s degree preferred
Experience
5+ years management experience preferred.
Experience leading conversations with customers and auditors preferred.
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
Proven understanding of GMP/GDP principles pertaining to a pharmaceutical distribution environment including shipper and lane qualification preferred.
Leading and hosting audit executions for regulatory and customer inspections.
Knowledge, Skills, Abilities
Proficient in state licensing regulations.
Excellent interpersonal skills
Ability influence others and lead significant change
Exhibit drive, creativity, collaboration, assertiveness, good judgment, and decision making
Good verbal and written communication skills
Critical thinker and problem solver
High attention to detail
Ability to travel 10%-20% of the time
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.
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.
Standard (Mon-Fri)
Environmental Conditions
Office
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
Located at the Swedesboro, NJ site and supporting the Clinical Trials Division (CTD).
Discover Impactful Work:
Within the Clinical Trials Division, we provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the patient. The Senior Quality Manager will develop, implement and maintain the activities of the Quality function and lead colleagues across the global business reporting to them. In addition, they will help establish, maintain, and strengthen the Quality Assurance and Quality Control processes to ensure compliance of product and systems to customer and regulatory requirements.
A Day in the Life:
Promote and facilitate a safe work environment for all employees and take appropriate action to correct unsafe acts and procedures
Strengthen and improve the Quality Management System by coordinating various areas, such as Distribution Quality Assurance, auditing, document management, and CAPA resolution throughout the organization.
Be a cross functional global leader providing expertise and direction to the wider organization related to logistics.
Lead the operational quality function for the Clinical Ancillary business in North America including support for procurement, kitting and distribution.
Responsible for quality oversight and leadership for the Transportation and Logistics functions within the Pharma Services Group, including but not limited to:
Third party distribution depot/subcontractors
Courier and transportation services
Shipping validation services
Provide strategic insight and develop solutions for the logistics business to improve existing services and expand to new markets. This includes; cold chain shipping and specialization making Thermo Fisher a market leader
Cultivate a partnership with Operations to drive a culture of continuous development of quality processes
Apply a "Decision-making" approach to Quality issues that will lead to a well-rounded Root Cause and Corrective Action.
Look to improve the Distribution Quality function, including a focus on reducing customer complaints.
Define metrics that matter for quality and the operational teams.
Deliver mentorship for product-related investigations, deviations, change controls, and validation reports.
Serve as the main contact for any significant quality issues and advise the Sr Director, Quality and General Manager for the business.
Participate, lead, and drive Continuous Improvement – PPI (Practical Process Improvement) events by encouraging employees to enter JDIs (Just Do Its) and perform Gemba’s
Partners across departments and sites to ensure resolution of non-compliance occurrences
Work as a leader, provide, assistance, and support the Quality team for the overall quality management
Other duties as assigned including special projects relevant with skills and experience.
Keys to Success:
Education
Bachelor’s Degree in a science related field, Master’s degree preferred
Experience
5+ years management experience preferred.
Experience leading conversations with customers and auditors preferred.
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
Proven understanding of GMP/GDP principles pertaining to a pharmaceutical distribution environment including shipper and lane qualification preferred.
Leading and hosting audit executions for regulatory and customer inspections.
Knowledge, Skills, Abilities
Proficient in state licensing regulations.
Excellent interpersonal skills
Ability influence others and lead significant change
Exhibit drive, creativity, collaboration, assertiveness, good judgment, and decision making
Good verbal and written communication skills
Critical thinker and problem solver
High attention to detail
Ability to travel 10%-20% of the time
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.
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.