Sr. Manager – QA Night Shift Position Available In Merrimack, New Hampshire

Sr. Manager QA Night Shift locations
US, Concord NC
time type
Full time
posted on
Posted 26 Days Ago
job requisition id
R84877
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring lifechanging medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Night Shift Manager, Quality Assurance (QA) – Parenteral (PAR), will initially serve as the QA representative supporting the Parenteral workstreams (Formulation, Filling and Visual Inspection) overseeing commissioning and qualification at Lilly’s new Concord, North Carolina site. This role is responsible for QA technical oversight including document approvals (e.g., Commissioning and Qualification Packages, procedures) and crossfunctional decision making. As the project progresses, this role will transition to providing leadership, daily support, and oversight of GMP operations. The Manager, Quality Assurance will develop the quality on the floor programs to support GMP manufacturing. The Manager, Quality Assurance will assist with developing the training program for floor support and training QA personnel. The Manager, Quality Assurance will be responsible for managing the daily work of QA personnel.

Responsibilities:

The Night Shift Manager, Quality Assurance, will support the startup and routine operation of the QA organization overseeing Parenteral operations at Lilly’s Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.
Serve as technical resource to review and approve technical documents Network with crossfunctional technical project delivery team 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 focus on the formulation, filling and visual inspection programs
Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production Manage a team of up to approximately 15 direct reports
Support the site to ensure a safe work environment including supporting and leading safety efforts for your team Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls Foster a strong quality culture including 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, etc. Network with global and other parenteral sites to understand best practices and share knowledge
Work crossfunctionally with the 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, pharmaceuticalrelated field of study or equivalent experience.
5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a crossfunctional group

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 problemsolving and decisionmaking skills
Previous facility or area start up experience Previous equipment qualification and process validation experience Previous experience with highly automated syringe filling and visual inspection 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 8hour days – Monday through Friday Night Shift
Ability to work overtime as required Ability to travel 1025% 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 a position at Lilly, please complete the accommodation request form (careers.lilly/us/en/workplaceaccommodation) 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.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Our current groups include:

Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$91,500 $134,200
Fulltime equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a companysponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and wellbeing 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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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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