1+ months


Kelly Services
Summit, NJ 07901
**BH: 3613741**

***** MUST BE ABLE TO WORK ON A W/2 HOURLY BASIS** **_(without Sponsorship)_** ******* **_NO C2C_** ***** REMOTE & ONSITE BLEND *****

**_Our Client is expanding and currently seeks a_**


**Leverage your** **GxP** **and Data Integrity experience** **to take your CAREER to**

**the "Next Level" for** **_2021 and beyond!_**

**Duration:** 12+ months with possible extensions!! **_Could go Direct!!_**

**LOCATION:** Summit, New Jersey

**Position is currently remote, after the COVID restrictions are lifted must report to the office.**


Our Client currently seeks a results-oriented Data Integrity Manager to work with Procedural Documentation Manager for ongoing integration and optimization initiatives, ensuring new processes align with global internal and external regulatory requirements for the Device and Combination Product organizations.

The position is in the Global Quality Systems- Device and Combination Quality department within the Global Quality Systems organization and is responsible for providing support to the Lead for the Director of QMS for Devices across the end-to-end product lifecycle to ensure that regulatory and Client requirements are addressed thoroughly and effectively in a timely manner.

The Data Integrity Manager will help design and implement a restructured role-based training curricula and develop tools for training needs identification specific to the Device organizations (Quality, MS&T, and Device Development teams). Once the new structure is developed, the candidate will then develop tools to align with global requirements to reconcile/remediate training assignments to all personnel across Device Quality.

In addition, you will create quality checklists for global Level 1 and Level 2 processes, and then review all local procedures using the created checklists, and compile a list of gaps noted.


Experience in a Quality Role.

Experience working with Medical Device/Combination products preferred, particularly EU MDR requirements and ISO13495.

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 device development, MS&T, and cross functional quality organizations.

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 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.

**Education:** MUST have a 4 year degree

**Important Information:**

**There is no per Diem with this position**

**There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.**

**MUST be able to work without sponsorship or VISA transfer for this position.**


**Why Kelly** **** **?**

By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-08-13 Expires: 2021-10-14

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Kelly Services
Summit, NJ 07901

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