GxP IT Quality Assurance Analyst GxP ITQA Quality and eCompliance

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Key Responsibilities and Major Duties

General Activities


Provide quality assurance oversight across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.









Carries out functions of the GQ GxP-ITQA Quality and eCompliance tower as directed including but not limited to:









Review and approval of key computer system validation life cycle (VLC) deliverables

Oversight of key software development life cycle (SDLC) processes such as problem, incident, change, release, deviations, etc.

QA Review and approval of validation deliverables associated with various BMS systems such as clinical study databases electronic Case Report Forms (eCRF) and Interactive Response Technologies (IRT), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, local laboratory systems such as FTIR or HPLC systems and others as required.

Ensure adequate and timely quality assurance / regulatory compliance support

Report on key metrics across the tower

Provide support during regulatory agency and third party inspections

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

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 ITQA Compliance tower meetings

Attend GQ ITQA departmental meetings

Interface meetings with functional areas supported

Departmental meetings

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)


Key Stakeholders/Contacts


Lead of the GQ ITQA eCompliance tower

Other members of GQ GxP-ITQA and department management.

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

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

Information Security

Validation Services

Service and Provider Quality Management

Hosting Services

Contracted Enterprise Service Providers





Management and staff of the associated quality departments


Degree/Certification/LicensureUniversity graduate (science degree preferred)• University Graduate; BA/BS Life-Sciences degree or diploma preferred. • Master of Science with 3 years’ experience or a Bachelor of Science with 5 years’ experience or Diploma holders with commensurate experience in regulated industry (e.g. 10 years) ; • Minimum 3 years’ experience in regulated industry required for all candidates.

Experience – Responsibility and minimum number of years• Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures.

Key Competencies – knowledge, skills, abilities, other


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 computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA preferred.

Experience in industry accepted software development and validation life cycle programs and related IT controls. Previous experience in risk-based approach to computerized system validation a plus.

Understanding of quality risk-management concepts (ICH Q9) preferred.

Familiarity with the drug 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.

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

Able to work effectively with multicultural workforce.

Excellent team player attitude.

Ability to manage competing priorities.


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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