Overview
Associate – QA Clinical Trial Packaging Jobs in Indianapolis, IN at Lilly
Job Title: QC Raw Materials PCU Leader
Location: Northborough, MA
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
The Quality Control Department is responsible for the testing of Raw Materials and Components for use at Massachusetts manufacturing sites. The Quality Control Department is also responsible for sampling and testing Packaging Components, Single Use technology and any other element that is required for manufacturing and/or packaging of Drug Substance/Drug Products. The department is responsible for the management and continuous improvement for control, testing, and inspection of raw materials.
Other responsibilities include life cycle management of methods and analytical instrumentation, environmental monitoring.
The department has expertise in Method Validation, Raw Material onboarding, Analytical techniques, with the ability to provide site support for investigations.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**This is an onsite role Monday-Friday that may require early morning/late evenings when necessary. Weekends as per business needs. **
Main Responsibilities:
This position provides leadership and direction through management and professional staff.
Responsible for the Chemistry operational and technical services functions within the Quality Control Raw Material organization
Leads chemical raw material onboarding, testing, and lifecycle management
Responsible for method development, validation and optimization
Directly responsible for all out-of-specification/unexpected results, laboratory events, and quality events regarding chemical raw materials in compliance with federal regulations and Sanofi standards
In-depth knowledge of GEMBA problem solving tools including Ishikawa, Fishbone, 5 Why’s, root cause analysis, and risk assessments
Facilitates the implementation and maintenance of Quality methods, processes and operations for new or existing products and/or technologies.
Participates in department budget planning
Specific CGMP responsibilities include:
Maintaining a safe, efficient, functional and compliant laboratory developed to the required standards in accordance with site and corporate guidelines
Developing strategies to continuously improve data management practices and test method reliability and repeatability
Ensure inspection readiness and actively participate and lead audits as it pertains to impacted areas
Actively influencing the development and formalization of corporate laboratory control standards, policies and guidelines
Contribute to framework for department objectives, operation schedule, processes and budgets
Providing effective leadership including developing and implementing objectives and goals, performance reviews, training and development, and supporting workforce diversity in alignment with site priorities
Ensuring compliance with all legal and business requirements and Sanofi policies and practices.
Provides Raw Material expertise to the Sanofi network. Ability to work cross functionally both internally to Northborough as well as with other Sanofi sites
About You
Leadership Qualifications
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.
Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgement in performing our jobs.
Leading People Sanofi’s leaders motivate, inspire, build and retain highly effective manufacturing teams while managing for high performance and developing others. They are learners and courageous decision makers.
Leading the Business Sanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.
Basic Qualifications:
Bachelor’s Degree in a science or technical field and10 years of experience in pharmaceuticals or a related industry – required.
6+ years in a management/supervisory position – required.
An equivalent combination of education and experience – may be considered.
Preferred Qualifications:
Experience reading and interpreting complex documentation for compliance with procedures, standards, assay validation and qualification
Experience demonstrating initiative and attention to detail
Demonstrated strong understanding of the pharmacopoeias (US, EU, JP, and ChP).
Proven reliable communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management.
Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.
Proven ability to work cross-functionally within the greater Sanofi network
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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Title: Associate – QA Clinical Trial Packaging
Company: Lilly
Location: Indianapolis, IN
