Sharp Corporation
Director, Data Integrity
Sharp Corporation, Allentown, Pennsylvania, United States, 18103
SUMMARY:
The Data Integrity is responsible for leading and managing the organization's data integrity initiatives, with a focus on ensuring the accuracy, consistency, and reliability of GXP data across computerized and paper systems. The role will oversee the development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The Data Integrity Lead will work closely with IT, Operations, Quality and Engineering functions to enable Data Integrity compliance using a Quality risk management approach.
The primary responsibilities of this role include 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 Data Integrity Lead will also have responsibility for implementing a risk-based approach to any assessments associated with Data Integrity Management.
The Director, Data Integrity will drive a Data Integrity Management program across three facilities whose core businesses are similar. This 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 our operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:Develop and lead a Data Integrity Management Program, including defining objectives and scope, developing/refining data integrity standards and procedures, implementing processes and metrics to enable success.Serve as a Data Integrity subject matter expert (SME) during regulatory inspections, train/coach staff on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex, Annex 11).Report to the VP Quality for Commercial Packaging US and serve on the global Quality Leadership team.Develop data integrity site leads to enable the management of data integrity at a site level and to support the achievement of objectives.Ensure risk-based methodologies are understood and implemented as it pertains to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems.Work closely with the Data Governance team to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles.Collaborate cross-functionally 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.QUALIFICATIONS:
Prefer BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus.Prefer a minimum of 8 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 3 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.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.
SUPERVISORY RESPONSIBILITIES:
This position will have one direct report which may increase over time.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor and to perform tasks within close proximately to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.
This position may be based at any of the US commercial packaging sites and the individual will be required to travel between Sharp US commercial sites. Occasionally there may be travel required to other Sharp sites. The position is not a remote or hybrid position so the candidate is expected to be on site every workday.
DISCLAIMER:
This job specification is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
The Data Integrity is responsible for leading and managing the organization's data integrity initiatives, with a focus on ensuring the accuracy, consistency, and reliability of GXP data across computerized and paper systems. The role will oversee the development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The Data Integrity Lead will work closely with IT, Operations, Quality and Engineering functions to enable Data Integrity compliance using a Quality risk management approach.
The primary responsibilities of this role include 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 Data Integrity Lead will also have responsibility for implementing a risk-based approach to any assessments associated with Data Integrity Management.
The Director, Data Integrity will drive a Data Integrity Management program across three facilities whose core businesses are similar. This 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 our operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:Develop and lead a Data Integrity Management Program, including defining objectives and scope, developing/refining data integrity standards and procedures, implementing processes and metrics to enable success.Serve as a Data Integrity subject matter expert (SME) during regulatory inspections, train/coach staff on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex, Annex 11).Report to the VP Quality for Commercial Packaging US and serve on the global Quality Leadership team.Develop data integrity site leads to enable the management of data integrity at a site level and to support the achievement of objectives.Ensure risk-based methodologies are understood and implemented as it pertains to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems.Work closely with the Data Governance team to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles.Collaborate cross-functionally 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.QUALIFICATIONS:
Prefer BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus.Prefer a minimum of 8 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 3 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.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.
SUPERVISORY RESPONSIBILITIES:
This position will have one direct report which may increase over time.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor and to perform tasks within close proximately to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.
This position may be based at any of the US commercial packaging sites and the individual will be required to travel between Sharp US commercial sites. Occasionally there may be travel required to other Sharp sites. The position is not a remote or hybrid position so the candidate is expected to be on site every workday.
DISCLAIMER:
This job specification is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.