Job Summary
The Data Integrity Specialist will lead a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel to ensure all CGxP data is collected, protected, archived, preserved, and retrievable according to industry and regulatory guidelines for COMPANY. The primary responsibilities will be to provide gap assessments and status updates to senior management to maintain and improve data integrity. The Data Integrity Specialist will report to the Manager, Quality Assurance, supporting global quality for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, to achieve a high-quality product for the marketplace and business success for company.
Essential Duties
Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards. Establishes operational objectives and assists with developing, modifying and executing company policies.
Ensures all new and existing equipment is assessed appropriately and validated for its intended use and existence. Coordinates procedure/process testing and provides reviews of audit trails.
Provides gap assessments and status updates to senior management to maintain and improve data integrity.
Supports risk assessments to determine high risk equipment and determines appropriate corrective action.
Acts as administrator for site quality systems.
Leads departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity for both paper and electronic records, and good documentation practices.
Develops, manages, and updates procedures as necessary to ensure there is clear direction and understanding regarding awareness, responsibilities and the importance of corporate and regulatory requirements for data integrity compliance.
Supports creation and execution of change controls, and establishes user requirements for laboratory and operations equipment.
Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.
Leads and establishes, where necessary, a surveillance program to audit all laboratory and operational practices and staff for compliance with established documentation and data integrity standards, practices and procedures
Essential Duties and Minimum Requirement
Minimum BS degree, preferably in a scientific area. Minimum of ten (10) years of industry experience and minimum of five (5) years technical knowledge related to data from quality systems, or an equivalent combination of education and experience.
Excellent communication and negotiation skills; maintains high ethical standards, and enjoy working with people and information, making decisions, problem solving, making a difference and working in a leadership role.
Adheres to ethical and good clinical practices and the ability to work as part of a team. As well as work independently in a remote workforce environment.
Excellent organizational skills, with the ability to work on multiple projects with competitive timelines is required.
Project Management and/or prior management experience preferred.
Strong verbal, written, and interpersonal communication and presentation skills.
Must be capable and willing to travel (up to 15%), including the potential for international travel.
Must have a thorough understanding of applicable US and international GMP and GDP regulations/guidelines.
Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
Demonstrated ability to work effectively in cross functional team environment.
Good problem-solving and decision-making skills.
About the Company
Quality Confidential engages the industry’s best talent to offer customized compliance solutions to clients in the pharmaceutical, biopharmaceutical, and medical device industries. We work with our specialized consultants to provide personalized project planning to ensure client project goals are met. Quality Confidential prioritizes partnering with consultants who are highly skilled, experienced, and passionate about problem-solving.
OUR CULTURAL BELIEFS
Authentic Communication - I speak up to create transparent, thoughtful, and timely dialogue.
Service Excellence - I value every client experience and its impact on results.
Passionate Work Ethic - I hold myself accountable and maintain high standards.
Integrity Over Profit - I act with our clients’ best interests in mind.
Creating Partnership from the Heart - I partner with anyone, anywhere to achieve results.