Manager Data Integrity Metrics amp SOPs

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.

Position Summary / Objective

Establish, lead and manage an effective and regula

This role will focus on creating/maintain the Data Integrity policies/procedures and establish metrics to measure the effectiveness of the Data Integrity Governance program and is accountable to establish and maintain an enterprise-wide Data Integrity Governance system to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner. The role will also be accountable for supporting other Quality Programs as assigned.

Position Responsibilities and Major Duties

Principal Objective of the Position

Reporting to Associate Director, the Manager of SOPs/Metrics will manage the development, implementation and sustainability of quality and technical training solutions for Data Integrity Program. This position will ensure employees and contract staff meet compliance requirements relating to knowledge, skill and practices necessary for her/his job performance and that they remain prepared to perform assigned tasks.

Key Responsibilities and Major Duties


Establish metrics to measure the effectiveness of the data integrity program across all BMS Network.
Provide DI guidance and ensure the Systems/ process, implementation and change management of used across GxP operations are conducted in compliance with applicable global regulatory requirements and industry data integrity standards
Create/Maintain the Data Integrity policies and procedures.
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations
Provide expertise and guidance in interpreting global governmental regulations, agency guidelines and internal procedures to assure continued compliance across all computerized systems
Manage projects and training initiatives which directly support Network and GxP DI initiatives, to effectively implement strategic business objectives in driving quality, compliance and safety.
Provide adjunct oversight of regulatory compliance 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.
Provide active support during regulatory agency and third party inspections


General Activities


Develop and utilize metrics and KPIs to assure programs' success
Ensure compliance with all Company policies and procedures, including safety rules and regulations
Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers
Support the various audit program across and within departments around data integrity concepts and training
Adherence to BMS core behaviors


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

Key Stakeholders/Contacts


Head of the GQ GxP ITQA organization
Lead of the GQ GxP ITQA Quality and eCompliance
Direct (as needed) or contracted reports
Other members of GQ GxP-ITQA and department management.
Management and staff from the GPS and R&D departments involved in GxP regulated operations
IT Quality Management Services
Validation Services
Service and Provider Quality Management
Contracted Enterprise Service partners.
Management and staff directly responsible for the business operations of computerized systems
Information Technology staff at commensurate levels of the organizations
Management of the associated quality departments
Inspectors during the conduct of health authority inspections


Degree Requirements


B.S in science, engineering, biochemistry or related discipline, or its equivalent is highly desired, life Sciences preferred


Experience Requirements


A minimum of 2 years' experience and in-depth knowledge ofData Integrity requirements
A minimum of 6 years' experience and in-depth knowledge of GMP computer validation, and Part 11 requirements
Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 4 years' experience).


Key Competency Requirements


Bio-tech/pharmaceutical/GMP industry or experience in a highly regulated environment strongly preferred
Extensive knowledge of SOPs and GxPs and the know-how to work and manage within a regulated environment
Strong change management skills and demonstrated ability to simplify and improve business processes
Excellent leadership skills with the ability to motivate and manage a team with matrix reporting relationships
Adaptable to a fast paced, complex and ever-changing business environment
Effective verbal and written communications skills
Excellent verbal communication, documentation and technical writing skills
Demonstrated creative problem-solving skills under resource constraints and time pressure
Ability to demonstrate strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities
Must understand industry accepted software development and validation life cycle programs.
Strong sense of ethics, diplomacy and discretion.
Commitment to Quality.
Strong critical thinking to analyze complex situations and discern critical issues.
Able to work effectively with multicultural workforce.
Excellent team player attitude.


Travel Required

Up to 20%

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

N/A

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.

Company: Bristol-Myers Squibb

Req Number: R1526356_EN

Updated: 2020-06-10 00:00:00.000 UTC

Location: New Brunswick,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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