Data Integrity Lead

Merck Group • $104K — $156K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Computer Science, Information Technology, Biology, Chemistry, or related field.
  • 10+ years of experience in computer system validation and/or Data Integrity within the pharmaceutical or medical device industry.

Responsibilities

  • Ensure data integrity across all GMP systems and practices.
  • Develop and update company policies and procedures for Data Integrity compliance.
  • Create and deliver training on Data Integrity standards site-wide.
  • Lead and advise on data life cycle management from collection to retirement.
  • Conduct gap assessments against cGMP expectations in collaboration with functional areas.
  • Review and approve Data Integrity-related change controls and deviations.
  • Implement permanent corrective actions for data integrity system failures.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Additional prerequisites as outlined.
Full Job Description
Your Role:

This position is responsible for data integrity for GMP systems, ensuring they are aligned with cGMP expectations, internal SOPs and requirements, and global governance. Provides auditing support for the Quality Compliance department as it relates to Data Integrity.

Responsibilities include but are not limited to:
  • Data Integrity for all systems that contain processors and or generate data including lab, manufacturing, and IT based systems utilized in the support of cGMP activities, including executing and reviewing Data Integrity Assessments and Security Reviews.
  • As the cGMP Data Integrity Specialist, develop and maintain company policy and procedures related to Data Integrity.
  • Develop training curricula and provide training for and enforcement of data integrity policy and procedures site wide. Provide ongoing coaching to ensure effected personnel understand Data Integrity process and regulatory guidelines in preparation for internal/external audits
  • Runs meetings and advises from a cGMP perspective, the functional areas on strategies for the life cycle management of data residing within computer systems (i.e., collection, storage, maintenance, backup, recovery, archival, retirement).
  • Perform (lead) cGMP gap assessments with the functional areas for current data collecting systems against cGMP expectation and current industry expectations. This includes aid/develop 21 CFR part 11 assessments for new and upgraded systems and software. Manages meetings to drive closures of all Data Integrity Gaps.
  • Update system User Requirements, as necessary.
  • Review and perform approval of Data Integrity change controls, deviations and protocols finalized by other functional areas.
  • Continually improve Computer Systems Data Integrity by investigating, developing, and implementing permanent corrective and preventive actions for process/system failures. Coordinate investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues.
  • Other Quality System and Data Integrity functions as given to drive compliance and continuous improvements.


Who You Are:

Minimum Qualifications:
  • Bachelor's Degree in Computer Science, Information Technology, Biology, Chemistry, or other Life Science discipline.
  • 10+ years experience with computer system validation and/or Data Integrity in pharmaceutical/medical device industry.


Preferred Qualifications:
  • Leadership, negotiation, and conflict management skills.
  • Strong knowledge of EU, FDA and cGMP regulations related to the pharmaceutical and biotechnology industry.
  • Excellent interpersonal effectiveness and written communication skills.
  • Ability to influence and work independently and in a team environment.


Pay Range for this position: $104,100- $156,100 / year

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences from Merck Group. Discover the exciting and rewarding career opportunities that await.

SEARCH MERCK GROUP JOBS

READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Merck Group

More Pharmaceuticals & Biotech Jobs

Find similar Data Integrity Lead jobs:

NationwideIndianapolis, IN