Bristol Myers Squibb Manager, GxP ITQA Auditor in New Brunswick, New Jersey

MANAGER GxP IT QUALITY ASSURANCE (GxP ITQA Auditor)

Global Quality Functional Area Description

Global Quality GxP Information Technology Quality Assurance (GQ GxP-ITQA) ensures all GXP computerized systems across the end-to-end product lifecycle meet BMS standards and global regulatory authority requirements and expectations.

Principal Objective of the Position

The position is in the Global Quality GxP IT Quality Assurance department within the Audit Operations tower and is responsible for auditing all processes related to computerized system development, production use, maintenance and retirement to assess compliance with relevant e-record and e-signature regulations

Key Responsibilities and Major Duties

• Plan, organize, execute and document audits of regulated computerized systems and related operations and IT controls. The audits are intended to assess compliance with appropriate regulations, guidances and company procedures and help to assure the quality and integrity of the data collected from these systems. Includes internal and external (vendor and/or contract service provider) audits.

• Utilize a risk-based approach in the development of audit scope with focus on critical IT controls impacting patient safety, product quality and data integrity.

• Prepare clear, concise, accurate and evidence-based audit reports to effectively communicate audit findings and recommended corrective action to management. Discern significant audit issues and identify appropriate recommendations. Review and assess corrective and preventive action plans according to specified timelines to assure resolution of audit findings and prevent re-occurrence. Maintain detailed documentation supporting the audit.

• Maintain an in-depth knowledge of governmental regulations which impact the development and use of computer systems as well as relevant BMS policies and procedures.

• Analyze documentation, process information, technical configurations, or other client provided information and document the results of conversations and analysis.

• Research new technologies, understand existing processes, and reference recognized standards and frameworks

• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned

• Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.

• Identify opportunities for continuous improvement

• Adherence to BMS core behaviors

Meeting Participation

• Attend GQ GxP-ITQA Audit Operations tower meetings

• Attend GQ GxP-ITQA departmental meetings

• Interface meetings with functional areas supported

• Departmental meetings

Key Stakeholders/Contacts

• Lead of the GQ GxP ITQA Audit Operations Tower

• Other members of GQ GxP-ITQA and department management.

• Other GQ auditors in the preparation, conduct, reporting and follow-up of audits

• Staff from the GPS and R&D departments involved in GxP regulated operations

• Providers of computerized systems or those providers of services to BMS who use computerized systems

• Staff directly responsible for the business operations of computerized systems

• Information Technology staff at commensurate levels of the organizations including but not limited to:

o Information Security

o Validation Services

o Service and Provider Quality Management

o Hosting Services

o Contracted Enterprise Service Providers

• Management of the associated quality departments

SUMMARY OF QUALIFICATIONS

Education:

• University Graduate; BA/BS Life-Sciences degree preferred.

Experience – Responsibility and minimum number of years

• Preferred to have at least 6+ years of relevant auditing experience performing systems audits for FDA Part 11 and EU Annex 11 compliance.

• Relevant cGxP experience (cGCP, cGLP, cGMP) preferred

Key Competencies – knowledge, skills, abilities, other

• Experience with Trackwise or similar quality management systems preferred.

• Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required.

• Excellent analytical, interpersonal and communication skills, including written and verbal communication.

• Previous experience as a lead auditor preferred, but not required for a life sciences company regulated by the FDA.

• In-depth understanding of industry accepted software development and validation life cycle programs and related IT controls.

• Previous experience in risk-based approach to auditing and computerized system validation a plus. Understanding of quality risk-management concepts (ICH Q9) preferred.

• Ability to write audit observations clearly and concisely is a must. Writing samples are required.

• Strong critical thinking to analyze complex situations and discern critical issues.

• Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes

• Strong sense of ethics, diplomacy and discretion.

• Commitment to Quality.

• Able to work effectively with a multicultural workforce.

• Ability to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team.

• Ability to effectively work in multi-disciplined team environment to achieve goals.

• Highly collaborative and must embrace and support teamwork. The ability to communicate and operate effectively with all employee levels is required.

Travel Required (nature and frequency) About 25-50% travel to meet with stakeholders, attend professional meetings and seminars and to attend audit meetings both domestic and international

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled