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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

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally adopt as "There is a Patient Waiting." Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

Discover Impactful Work:

The Sr Quality Manager is responsible for supporting, and at times leading, the site in implementing and promoting cGMP, regulatory and company quality requirements for our global clinical supply chain services. You will mentor and empower a large Quality team to foster a dynamic environment committed to effective and timely quality assurance activities. You will take ownership of all quality efforts - assurance, compliance, support, control - to ensure they are well coordinated and driven in collaboration with cross-functional partners.

A Day in the Life:

• Applies Good Manufacturing Principles in all areas of responsibility.
• Demonstrates and promotes company vision.
• Performs all activities in a safe and efficient manner.
• Oversees and manages the FCS Allentown Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as the Deviation and Change Management systems. This includes ensuring timeliness, compliance, completeness and accuracy of system deliverables.
• Provides interpretation and recommends FCS Allentown's position on compliance with regulatory requirements related to Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as Deviation and Change Management.
• Supports the use of TrackWise for Change and Deviation Management deliverables and will be a "power user" supporting the department and site as needed.
• Ensure internal departments maintain the highest quality standards and are aligned with all regulations/procedures by driving continuous improvement activities.
• Provides leadership in promoting and enforcing GMP and company quality requirements.
• Resolves issues potentially affecting product quality/compliance.
• Evaluates and develops techniques designed to maintain awareness of SOP's, cGMP's and clinical requirements.
• Maintains excellent client relationships by providing a technically competent QA Dept.
• Advances quality events (as necessary) to QA Director and works with QA Director to periodically review significant quality aspects of Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as Deviation and Change Management.
• Quality Sponsor and interacts with clients on quality issues and is an advocate on the company's quality concept.
• Implements and monitors key performance indicators within area of responsibility.
• Provides supervision of direct reports in support of their activities.
• Provides or assists on employee training to ensure compliance with procedures and regulations.
• Provides suggestions and improvement ideas to the Quality Director related to work related processes and procedures.
• Supports and assists on regulatory and client audits.
• Assist in conducting investigations when applicable.
• Supports Quality Council and Global Quality Leadership Team initiatives.
• Other duties may be assigned to meet business needs.
• Responsible for supervising, training, reviewing, and motivating approximately 6 direct reports.
• Conducts all activities in a safe and efficient manner.

• Bachelor's degree is required.
• MS degree is preferred.

• Minimum of 5-8 years of experience in the Pharmaceutical or highly regulated industry and at least 3-5 years of direct supervisory experience required.
• Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others), people management required.
• Experience with QA procedures in a pharmaceutical, or highly regulated environment with emphasis on documentation.

• Must have extensive familiarity with packaging paperwork and a sound understanding of cGmp's and SOP's.
• Capable of effectively managing up to 10 direct reports in a dynamic environment.
• Proficient communications skills when interacting with both internal and external parties.
• Extensive familiarity with packaging paperwork and a sound understanding of CGMP's and SOP's.
• High ethical standards required to uphold compliance.
• Thorough knowledge of Current Good Manufacturing Practices and SOP's.
• Sound knowledge of clinical packaging operations and strong leadership ability.
• Comfortable with decision-making on diversified issues and communicating directly with customers on a routine basis.
• Good organizational skills.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
• Ability to manage personnel in a cGMP environment.

• The position is administrative, is positioned in an office environment and requires standing, bending, reaching, walking, and talking as well as exerting up to 20lbs of force occasionally.