The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Quality - Data Integrity Manager in Princeton, NJ.

Role Description
• 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 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

Skills & Requirements

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

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be
working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.

We also believe that actions speak louder than words.

In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.