Position Summary
The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site’s development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach.
The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization.
The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks.
The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally.
Duties and Responsibilities
- Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program.
- Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA’s Guidance for Industry, “Data Integrity and Compliance with Drug CGMP: Questions and Answers” (Final, 2018)).
- Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums.
- Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives.
- Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems.
- Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles.
- Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management.
- Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers.
- Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans.
- Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities.
- Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness.
- Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions.
Regulatory Responsibilities
- Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations
- Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity.
Supervisory Responsibilities
- This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program.
Experience
- Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation.
- Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required.
- Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization.
- Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations.
- Demonstrated history of influencing, motivating and effecting change with cross‐functional teams.
- Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications.
- Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience.
- Ability to influence and engage stakeholders at all levels.
- Excellent project management skills with the ability to manage multiple initiatives simultaneously.
- Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights.
- Experience of working in a sterile pharmaceutical manufacturing environment preferred.
Education
- BS or higher degree in an IT, engineering, scientific discipline or other related field. A master’s degree is a plus.
Knowledge, Skills & Abilities
- Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat
- High attention to detail
- Good writing, public speaking and presentation skills
- Must be able to travel approximately 10% of the time
Physical Requirements
- Ability to sit for prolonged periods of time
- Ability to stand for prolong periods of time as required
- Able to lift up to 10lbs