Compliance Specialist

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.

PRINCIPAL OBJECTIVE OF POSITION

Global Quality, Quality Laboratory Practices (GQ-QLP) is responsible for regularly evaluating key clinical and preclinical research processes to determine compliance with regulatory requirements, guidelines and established standard operating procedures with an emphasis on technical expertise, regulatory risk, and quality advice. GQ-QLP is also responsible or coordination/management of regulatory agency inspections and for providing advice on company quality and regulatory agency requirements.

The key objectives of this position are:


To conduct audits of clinical and preclinical laboratories that perform bioanalytical and biomarker work under the Good Clinical Laboratory Practices (GCLP) guidelines as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations.
To act as a quality and compliance subject matter expert (SME) to key stakeholders in GCLP, GLP, GCP related areas.
To coordinate/manage regulatory inspections.


MAJOR DUTIES AND RESPONSIBILITIES

Maintain an in-depth knowledge of governmental regulations that impact the research and development of medicines as well as the relevant **MEMBERS ONLY**SIGN UP NOW***. policies and procedures associated with bioanalytical and biomarker analyses supporting clinical (GCLP and GCP) or preclinical (GLP) research. Act as an SME with key stakeholders and provide advice and counsel concerning GCLP, GLP and GCP regulatory requirements. Conduct Quality System audits at various internal R&D sites/functional areas and external contract laboratories to assess compliance with governmental regulations, study protocols and established operating procedures.

Compile documentation in preparation for the audit.

Conduct audit in accordance to the audit plan.

Prepare clear, accurate, and evidence-based audit reports to effectively communicate the audit findings.

Review and assess corrective action plans and follow-up on the resolution of audit findings.

Keep clear and detailed documentation on every audit planned, performed and followed.

Maintain the audit database.

Lead or participate in cross-functional audits (domestic and international) with other auditing teams and/or with stakeholder involvement. Conduct other audits or investigations of regulatory concern as directed by GQ-QLP management. Lead QLP project teams/initiatives and participate in GQ enterprise projects/initiatives. Assist in the preparation of departmental standard operating procedures. Participate in the preparation and conduct of regulatory training given to personnel involved in the conduct of preclinical and/or clinical studies. Lead or coordinate QLP inspection readiness activities. Coordinate/manage regulatory agency inspections (e.g., FDA) and associated activities. Adherence and demonstration to BMS core behaviors with enhanced capabilities as a team player, mentor or model to others, and leadership potential.

IMPACT

Bristol-Myers Squibb efforts focuses on discovering, developing and gaining approval of ethical drug products. The drug development process is governed by various regulations. Non-compliance with these regulations can result in a loss of or delay in marketing approval for new products and/or pose the threat of significant financial and legal liability to the company.

GQ-QLP is responsible for auditing laboratory processes related to studies supporting clinical and/or preclinical research to assess compliance with relevant regulations. This position is expected to be involved in all aspects of GQ-QLP operation.

DECISION MAKING

This position is responsible for regularly evaluating key bioanalytical and biomarker development processes to determine compliance with regulatory requirements and established standard operating procedures. Noncompliant situations must be identified and appropriate corrective and preventative actions recommended. Recommendations must be ethical, scientifically sound, consistent with company policy and strategy, and cost-effective. Good judgment and a sense of discretion are required given the potential risks and consequences of the decisions.

Audit and inspection strategies and priorities are established with supervisory oversight. Minimal supervision is received during the actual performance of duties. Job results receive careful supervisory review.

CONTACTS

Daily collaboration with other GQ-QLP auditors, other GQ auditing groups and R&D stakeholders in the preparation, conduct, reporting and follow-up of audits. Regular and appropriate contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections. Interaction with scientific, quality, and managerial personnel at contract research organizations during evaluation of these facilities (8-10 times/year). Close working relationship with external auditors and inspectors (e.g., FDA) during the conduct of their inspections (1-2 times/year). Regular and appropriate reporting relationship to GQ-QLP management Miscellaneous contacts as assigned by GQ-QLP management.

KNOWLEDGE/SKILL

University graduate (Life Sciences degree preferred). At least 4 years audit experience or experience in a highly regulated environment. At least 6 years experience in the biopharmaceutical industry or related technical field. Good understanding of the drug development process and comprehensive knowledge of regulations relevant to clinical and/or preclinical research. Strong critical thinking to analyze complex situations, discern critical issues, and to recommend appropriate corrective and preventive actions. Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, during the audit process. Sense of diplomacy and discretion. Sound knowledge of quality risk management. Ability to identify and escalate areas of high risk Ability to manage competing priorities. Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment. Effectively communicate verbally and in writing and able to impact and influence people. Good presentation skills, deliver focused message to audience of peers and stakeholders. Develops strong working relationships with key stakeholders and works effectively with a range of technically and culturally diverse people, including regulatory agency personnel. Able to function independently within an environment that relies heavily on technology for information and communication. Good judgement and sense of discretion. Project management and organizational skills.

BEHAVIORS REQUIRED

Passion Innovation Accountability Speed

Travel required (describe nature and frequency):

Approximately 25 % travel, including overnight, may be required in this position. These trips will include travel to BMS sites and contract research organizations (U.S. and International) to conduct audits and to attend professional meetings and seminars.

Overnight absences required (per typical month):

Overnight travel may include approximately one trip every month with stays of up to four nights.

Describe exposure to any hazards/disagreeable conditions in the work environment:

This position may require employee exposure to chemical or biological agents that may pose health or safety hazards if improperly handled during routine laboratory tours/audits

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: R1522812_EN

Updated: 2020-03-11 00:00:00.000 UTC

Location: Princeton,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.

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