Senior Data Integrity Specialist

SUMMARY:

The Sr. Data Integrity Specialist will concentrate on delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards. The position will support the Data Integrity Governance program through assessment/remediation activities and is responsible for maintaining the Sharp US Commercial-wide Data Integrity governance system, ensuring that all regulatory and Sharp requirements are met comprehensively and promptly. Additionally, the role involves communicating data integrity principles and training individuals at all levels within the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to the Senior Data Integrity Specialist position. Other duties may also be assigned.

• Possess advanced understandings of GMP and GDP regulatory requirements regarding drug, device, and drug-device combination products.

• Provide day-to-day support for the governance, management, coordination, and implementation of activities related to the Data Integrity activities across Sharp US Commercial sites and in alignment with relevant governmental regulations and guidelines.

• Responsible for developing, reviewing, and approving appropriate Sharp policies and procedures (including safety rules and regulations) and coordinating all relevant activities between Quality, IT and other departments in relation to implementation, maintenance and change management of assigned programs.

• Support and manage remediation efforts, utilizing Quality Risk Management (QRM) based principles to identify risk and establish appropriate prioritization.

• Provide active support during regulatory agency and third-party inspections.

• Support knowledge transfer and training to departmental team specific to data integrity requirements.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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 commercial operations, and manufacturing functional and site leaders

• Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites

• Demonstrate the ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives

• Experience with senior level interactions and influence with Manufacturing Operations, Regulatory, and Commercial functions

• Ability to demonstrate strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities

• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights

• Able to work effectively with multicultural workforce with a team player attitude

SUPERVISORY RESPONSIBILITIES:

Moderate, including scheduling, oversight of assigned projects, and supporting Data Integrity Director as requested.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Associate or bachelor’s degree is preferred with a minimum of four (4) years of direct Data Integrity experience.

• Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired

• Experience in the pharmaceutical industry is required with good understanding of the drug and device process from regulatory filing and approval of drug applications as well as commercial manufacturing processes

Essential skills include:

• Exceptional documentation and interpersonal skills, including written and verbal communication

• Excellent organizational and planning skills with strong critical thinking to analyze complex situations and discern critical issues

• In depth knowledge of data integrity regulations, GxP Computer System Validation (CSV), industry accepted SDLC and qualification programs, and Part 11 requirements

• Ability to multi-task, be transparent, reliable and deliver on commitments/ timelines

• Strong sense of ethics, diplomacy and discretion

• Experience in working in the matrix and challenging self and others to continuously learn and improve

• Ability to work effectively with multicultural workforce with a team player attitude

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation 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. The working environment is clean and not normally subject to hazardous environment or conditions.

DISCLAIMER:

This job description 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.