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QA Manager-Night ShiftBioSpace • Concord, California, United States
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QA Manager-Night Shift

BioSpace
  • US
    Concord, California, United States
  • US
    Concord, California, United States
Postuler Maintenant

À propos

Night Shift Manager, Quality Assurance (QA) – Device Assembly and Packaging (DAP) The Night Shift Manager, Quality Assurance will support the start-up and routine operation of the QA organization overseeing Device Assembly and Packaging operations at Lilly’s Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership as well as project management.
Responsibilities
Serve as a technical resource to review and approve technical documents
Network with cross-functional technical project delivery teams to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
Work with the Associate Director, Quality Assurance to support the development of the vision, strategy, and quality culture for the overall site quality assurance organization with a focus on the device and packaging programs
Support initial recruiting, build capability, and develop a diverse leadership and quality assurance staff to support qualification, validation, and routine production
Manage a team of up to approximately 14 direct reports
Support the site to ensure a safe work environment, including leading safety efforts for the team
Support the development of the overall site operational readiness plan, including the development of quality processes and approval of operational procedures and controls
Foster a strong quality culture by maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
Review and approve GMP documentation, including procedures, deviations, technical reports, change controls, and more
Network with global and other device assembly sites to understand best practices and share knowledge
Work cross-functionally with area process teams for metrics reviews, operational support, and issue/deviation management
Support inspection readiness activities
Interact with regulatory agencies during inspections regarding cGMP issues
Ensure data integrity by design
Basic Requirements
Bachelor’s degree in a science, engineering, pharmaceutical‑related field of study or equivalent experience
5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross‑functional group
Qualified applicants must be authorized to work in the United States on a full‑time basis; Lilly will not sponsor work authorization
Additional Skills & Preferences
Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) certification
Strong knowledge of Quality Management Systems and applicable regulatory requirements
Previous experience directly supporting a pharmaceutical manufacturing operation
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Demonstrated technical writing skills
Demonstrated problem‑solving and decision‑making skills
Previous facility or area start‑up experience
Previous equipment qualification and process validation experience
Previous experience with highly automated combination products and packaging equipment
Previous experience with Manufacturing Execution Systems and electronic batch release
CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
Previous experience with deviation and change management systems, including Trackwise
Additional Information
Ability to work 8‑hour days — Monday through Friday, night shift
Ability to work overtime as required
Ability to travel 10–25% or potentially relocate during the project phase to support the design and staffing of the facility
May be required to respond to operational issues outside of core business hours and days
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for this position, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $94,500–$138,600. Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits; life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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  • Concord, California, United States

Compétences linguistiques

  • English
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