Data Integrity Manager-Quality Assurance Job at TSR Consulting Services, Inc., New Brunswick, NJ

WWJ2MmwyZXc1eDZnZ2toOWJmU2FsTlJRaHc9PQ==
  • TSR Consulting Services, Inc.
  • New Brunswick, NJ

Job Description

Data Integrity Manager-Quality Assurance

Location: New Brunswick, NJ (50% onsite required)

Job ID # 82494

Rate type: W2 only

The position is located in the Global Quality GxP IT Quality Assurance department within the Data Integrity tower. It is responsible for providing support to the Lead of the GxP Data Integrity program across the end-to-end product lifecycle, ensuring that regulatory and client requirements are thoroughly and effectively addressed promptly.

Key Responsibilities and Major Duties

• Provide oversight for the governance, management, and coordination of activities related to the Data Integrity Governance Program, including directing, developing, and maintaining Data Integrity compliance activities across the end-to-end product and 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 programs across and within departments around data integrity concepts and training

Key Competencies – knowledge, skills, abilities, other

• 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 a multicultural workforce.

• Excellent team player attitude

Education

A university bachelor's degree in Life Sciences, with at least 5 years of experience in Data Integrity and GMP/CSV required.

Travel

• Travel to client sites (both US and outside US) may be required

Job Tags

Similar Jobs

Abbeyville Nursing & Rehab

Maintenance Manager Job at Abbeyville Nursing & Rehab

 ...impact in the communities we serve. Responsibilities: The Maintenance Manager will perform all maintenance duties at the Genesis corporate...  ...*Term and Whole Life Insurance *Short-term Disability *Hospital Indemnity *Personal Accident *Critical Illness *Cancer... 

Texas Department of Family and Protective Services

CPS Family Based Safety Services Worker Job at Texas Department of Family and Protective Services

 ...from abuse and neglect and keep them safe at home. This involves providing services offered by the agency, the family's community, and...  ...objectivity and empathic understanding when engaging families living in stressful and crisis situations. Develops and maintains effective... 

Artemis Consultants

Executive Recruiter Job at Artemis Consultants

 ...Recruiter to join the Artemis Consultants team in Columbus, OH. This person will be responsible for working with our recruiters to help manage the day to day tasks of full-cycle recruiting on a National level. You will work closely with the team to employ all best-in-class... 

Mosaic

Specialized Home Provider - Garden City, KS Job at Mosaic

Are you looking for a meaningful work opportunity in your home? Become a Host Home / Shared Living provider with Mosaic at Home! Average annual income of $47,000 (federally tax-free) plus monthly rent/household expenses. You must reside in the state of Kansas (due to ...

Catalyst Health Group

Family Medicine Physician Job at Catalyst Health Group

 ...approximately 5% pediatrics. Enjoy the convenience of onsite lab and X-ray facilities, along with the flexibility to send labs to LabCorp when needed. Your Responsibilities Provide comprehensive healthcare services to patients of all ages. Collaborate with advanced...