Data Integrity Manager - Quality Assurance
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Data Integrity Manager - Quality Assurance for our client in New Brunswick, 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 GxP IT Quality Assurance department within the Data Integrity Governance tower and is responsible for providing support to the Lead for the GxP Data Integrity Governance program across the end-to-end product lifecycle to ensure that regulatory and Client requirements are addressed thoroughly and effectively in a timely manner.
- Provide oversight for the governance, management and coordination of activities related to the Data Integrity Governance Program include directing, developing, and maintaining Data Integrity compliance activities across the end-to-end product and across all Client sites and internal functions in alignment with relevant governmental regulations and guidelines.
- Assist in conducting data integrity gap assessments, develop remediation plans and strategies, and manage tasks towards execution
- Develop and utilize metrics and KPIs to assure programs’ success, and develop data analytics management processes
- Utilize visualization technologies to create information from various data sets and sources
- Ensure compliance with all Company policies and procedures, including safety rules and regulations
- Support the various audit program across and within departments around data integrity concepts and training
- Cross-functional experience in three or more areas (i.e. IT, Computer System Validation, Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired
- 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 including research & development, commercial operations and manufacturing regional and site leaders
- Ability to demonstrate strategic thinking capability with strong project management focus 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 software 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, please contact Pat Bandiwan at Pat.Bandiwan@eclaro.com or at 212 258 2279 and or at http://www.linkedin.com/pub/patt-bandiwan/7a/900/400
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.