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.
The Senior Manager, Manufacturing Quality Assurance provides quality oversight to the Steriles manufacturing operations ensuring continuation of DPI's pharmaceutical license to operate from a Current Good Manufacturing Practices (cGMP) compliance standpoint and to ensure no harm is done to patients due to errors and deviations of DPI's manufacturing activities. Ensures best-in-industry as it relates to continuous improvement by increasing quality, compliance, and efficiency standards.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best. Sets strategy and direction for Steriles Manufacturing / O&T 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. Represents Steriles Manufacturing / O&T Quality Assurance in all Regulatory and Customer Inspections. Ensures efficient operations to support DPI's commitments to customers regarding product delivery and project deliverables. Provides responsive service to internal and external customers for Steriles Manufacturing Quality Assurance. Represents Steriles Manufacturing / O&T Quality Assurance on the Quality Governance committee. Represents Steriles Manufacturing / O&T Quality Assurance in quality and compliance issues. Develops and maintains professional relationships with all stakeholders. Ensures adherence of Steriles Manufacturing and Packaging to all relevant worldwide regulatory requirements. Provides systems to maintain compliance with these requirements. Remains current in relevant worldwide regulations pertaining to Steriles manufacturing quality assurance. Advises quality top management on issues that may affect Steriles / O&T and/or DPI as a whole. Manages and Develops staff in order to realize Environmental Health and Safety (EH&S), Quality and business goals.
Education
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
This 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.
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!
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. 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.
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