Manager Data Integrity Network Communication amp Training

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 training and implementation of appropriate network communication support for 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 Training 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

Develops and executes DI Training strategy - including working with stakeholders to determine learning needs and priorities and provides appropriate training to meet those learning needs.

Evaluate training needs and participates in the development and delivery of DI training materials, for network initiatives, including but not limited to Quality and GxP functions as needed.

Maintain and improve onboarding experience in alignment with network deliverables

Develop training materials, in collaboration with SMEs, for existing employees ensuring all aspects of job responsibilities and expectations are met to improve efficiency, effectiveness and compliance and address gaps appropriately.

Lead DI Community of Practice and Governance meetings across the BMS DI Network. Partner with colleagues across DI Network to construct and execute insight-led communications strategies that advance business outcomes.

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 guidance and information to leadership on recommended training programs, curricula and training material development, and learning assignments

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: R1526354_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

Bristol-Myers Squibb Company
Website : http://www.bms.com