Data Integrity Site Lead

Company Description

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, a place to call home, apply with us today!  

Job Description

POSITION SUMMARY:

This position will support the Quality Assurance department by serving as the champion for the site Data Integrity program; is assigned the oversight and sponsorship of the overall site approach and is actively engaged in strengthening the site data controls and individual accountability for the integrity of GMP data at the site through facilitation education, awareness and reporting.  You will serve as the point of contact for center Data Integrity program office and is accountable to facilitate appropriate site-based initiatives to ensure effective rollout of Data Integrity program elements launched by center.  Engaging, communicating, and influencing the site leadership team will be instrumental in achieving a quality culture aligned around the importance of achieving good data management practices.  The emphasis of this role is sponsorship and assurance of adequate Data Integrity program actions and awareness. 

POSITION RESPONSIBILITIES:

• Develop, manage, and execute the site Data Integrity program at the site.
• Work with site leadership and partner with Center colleagues to develop and maintain a robust site strategy, including action plans, to ensure data management practices are compliant with Pfizer and regulatory expectations.
• Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
• Drive effective management of quality issues and make decisions that may involve complex quality and technical issues.
• Communicate with and influence internal and external customers across the site and department boundaries to ensure compliant and aligned resolution of project related issues.
• Contribute to Quality Assurance by undertaking a variety of roles and assignments to further develop internal processes and people.

Qualifications

BASIC MINIMUM QUALIFICATIONS:

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associates Degree with 8 years of experience OR a Bachelors Degree with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience. Relevant pharmaceutical experience (Quality Operations)
• Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity
• Demonstrated knowledge and awareness of Data Integrity and potential impact on site operations
• cGMP experience with compliance issues
• Proactive approach and strong critical thinking skills
• Project Manager, team leader/project leader or coach
• Strong oral and written communication skills
• Strong verbal and written English communications capabilities

PREFERRED QUALIFICATIONS:

• Demonstrated previous experience in problem solving, decision making, negotiating and conflict resolution skills
• Capability in Lean tools and/or desire to grow Lean capabilities to further drive Continuous Improvement projects.
• Functional knowledge of Microsoft SharePoint and Office applications, particularly Excel

Additional Information

Position is Full Time, Monday-Friday, 8:00am-5:00pm with overtime and weekend work as needed. Candidates currently living within a commutable distance of  Sanford, NC are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.