Data Integrity Manager
Data Integrity Manager
Job Number: 21-12472
Job Number: 21-12472
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Data Integrity Manager for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The position is in the Global Quality Systems- Device, Packaging and Combination Product Quality department within the Global Quality Systems organization and is responsible for providing support to the Associate Director of Packaging and Combination Product Quality for Commercial Packaging and Labeling activities across the end-to-end process to ensure that regulatory and Client requirements are addressed thoroughly and effectively in a timely manner.
- Participate in qualification of the packaging materials and thermal protection systems, provide technical quality inputs to ensure potential problems are identified and corrected earlier;
- Review and approve development, qualification, change controls, deviations, investigations and CAPAs as part of general quality support for MS&T, Global Logistic Services, Market Supply Operations;
- Assist root cause investigations, risk assessment and implementation of corrective actions;
- Ensure Design Controls and risk management elements, GMP and GDP are satisfied.
- Work with Labeling Office on ongoing integration and optimization initiatives, ensuring new processes align with global internal and external regulatory requirements for labeling activities of commercial products, including medical devices and combination products.
- This person will be the quality reviewer/approver of all labeling process related procedures and will participate as the QA representative on the End to End labeling Optimization team, communicating status, deliverables, and decisions made by the team to leadership; escalating concerns or issues to his/her manager in a timely manner as applicable.
- Experience in Commercial Packaging and Labeling in a Quality Role
- In depth knowledge of global regulations governing packaging and labeling of pharmaceutical, medical devices, and combination products.
- Recent Data Integrity experience in a GxP environment
- Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
- Provide subject matter expertise in regulatory requirements, expectations, specifications/methods/compendia, manufacturing technology, and/or quality assurance is required.
- Ability to build alignment with business partners in Packaging and Labeling Office and cross functional quality organizations
- Ability to demonstrate strategic thinking capability with strong project management skills as well as focus on execution of strategic decisions while balance conflicting priorities
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
- Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
- Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
- Must understand industry accepted device development and validation life cycle programs.
- Excellent interpersonal skills, including written and verbal communication.
- Strong sense of ethics, diplomacy and discretion.
- Commitment to Quality.
- Strong critical thinking to analyze complex situations and discern critical issues.
- Able to work effectively with multicultural workforce.
- Excellent team player attitude
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.