Manager - QA Document Control

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 life-changing 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.

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description: 

The Sr. Manager - QA Document Control oversees the performance of the Quality Assurance Document Control & Records Management team. The Sr. Manager facilitates the day-to-day scheduling and oversight of Document Control and records management activities and is responsible for maintaining records & retention according to cGMP requirements. The Sr. Manager - QA Document Control is responsible for administering the corporate Records Management Program at the NJ site, ensuring that GMP and non GMP records are processed, retained, and dispositioned per regulations, legal requirements, and internal Lilly Records Management Policies.  The position is also responsible for developing procedures, training, and systems to ensure the objectives of Lilly’s Document Control and Records Management Program are met and that resources are effectively utilized.

Key Objectives/Deliverables: 

Manage for Results /Strategic Planning: 

The following responsibilities apply to Quality Assurance respective to the specific area of oversight:
1. Promote a positive Quality Culture and oversee on-the-floor Quality presence in the area.

2. Oversee team who: a) assist in the development, optimization, and maintenance of Document Control systems to ensure compliance with FDA regulations and company policies and procedures, and b) are responsible for archiving of on-site and off-site GMP and Non GMP documentation, including maintaining Records Management database.

3. Provide Quality direction for complex business and operational issues or technical challenges.  Remove barriers as they arise. Represent Document Control in QA Initiatives and Cross Functional projects. 

4. Lead by example and build a strong, solution seeking, collaborative team that is flexible to shifting demands.

5. Oversee data integrity for paper based and electronic systems, including controlling access and roles for Document Management System. Ensure compliance with applicable Lilly global standards and regulatory guidelines.

6. Responsible for all QA Document Control/Records Management related deviations, change controls, and risk assessments.  Recommend CAPAs and ensure CAPAs implemented are effective. Revise and approve documents in QualityDocs, as applicable. 

7. Prepare site for regulatory inspections and support regulatory and business partner inspections/audits within specific area of oversight.

8. Collaborate with cross-functional departments during planning and process/continuous improvement projects and initiatives to ensure timely completion (e.g., Quality Plan objectives and milestones).  Identify and lead process improvement projects impacting Document Control/records management.

9. Oversee and monitor Quality metrics for the respective business area.  Ensure data compiled are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management.

10. Mentor, coach, and manage staff performance and development.

11. Plan, administer, and monitor the department budget, including coordination of contract staff.

12. Monitor workload for staff, reprioritize as needed to ensure completion of all tasks.  Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

13. Oversee implementation of continuous improvements to procedures, quality systems, etc. Ensure thorough and timely issuance, review, and retention of GMP records and escalate any compliance issues and/or potential delays to senior management.

Basic Requirements: 

• BA/BS degree in a sciences-related field, as applicable, with a minimum of 5 years technical and/or Quality experience in the Biopharmaceutical industry, preferred.
• Minimum of 2 years of management/leadership experience preferred.
• Minimum of 5 years of previous technical and/or Quality experience (i.e., production, validation, laboratories) in a GMP regulated environment.

Additional Preferences: 

• Requires technical knowledge/understanding of business linkages/drivers outside of own business area, the ability to make decisions guided by policies, and business plans that impact customer service and the work unit’s ability to meet performance objectives.
• Influences internal/external customers and management, has the capability to identify and solve a range of organizational and operational problems and technical challenges, able to proactively remove barriers, and influence a positive Quality Culture. 
• Must possess a working knowledge of domestic and international GMP regulations and other policies/regulations as applicable to the business area.  Strong knowledge in current Good Manufacturing Practices for pharmaceutical manufacturing.
• Must have a thorough understanding of data integrity.
• Must have experience in leading small/medium scale process improvement projects.
• Must have the ability to function in a fast-paced environment and communicate effectively cross-functionally, with staff, and management (both written and verbal).
• Must be proficient in Microsoft applications, Veeva QualityDocs, and quality systems.
• Able to work independently in a fast-paced environment to support production demands daily.
• Excellent leadership, communication and writing skills.
• Enthusiastic, positive attitude and flexible. Communicate effectively with cross functional counterparts internally and externally and break down barriers, as applicable.
• Strong organizational skills.

Other Information:  

• Shift work may apply.
• Travel required, approximately 5%.
• Lifting not required.
• Required to be on call.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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