Digital Plant Compliance Lead

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

MAJOR DUTIES AND RESPONSIBILITIES

Ensures Digital Plant systems are compliant and aligned to BMS policies and directives, regulatory requirements, and industry guidelines. Analyzes current / develop new work processes and Standard Operating Procedures (SOPs) to identify gaps and shortcomings. Propose process improvements and document such in appropriate procedures. Develops mechanisms and methodologies to improve operations. Generates applicable training to support procedures. Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors. Oversee contract validation engineers, supporting computer system validation activities for the site Leads and supports internal compliance and/or efficiency improvement efforts within department for more complex processes. Leads and supports investigations related to digital plan systems. Ensures CAPA action plans are robust and CAPA commitments are met on time and in an effective manner Leads site data integrity efforts in coordination with site quality assurance and the global data integrity team. Primary Digital Plant contact point for internal and external inspections and audits: co-ordinates identification of correct SMEs during Health Authority audits. Owns the periodic review processes and audit trail review processes for Digital Plant applications and assets. Assists in generating responses to audit observations. Effectively manages workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies. Establishes and communicates performance standards, defines clear accountability, and leads continuous improvement strategies to reduce operational variances and cycle time. This includes generation of quality council metrics, internal performance standards (ex - Right First Time) and training on time completion. Participates actively within Digital Plant and also with other groups to analyze and address process deficiencies. Work collaboratively with peers within the Validation, Manufacturing, Manufacturing Engineering and Quality groups.

KNOWLEDGE AND SKILL


Knowledge of IT and science generally attained through studies resulting in a B.S. in IT, a related discipline, or its equivalent.
Knowledge of Quality principles, System development lifecycles, and QA methodologies.
Detailed understanding of software and its application in a regulated manufacturing or laboratory environment.
Strong knowledge of cGMP, particularly as it applies to biologics manufacturing and automated systems.
A minimum of 3 years relevant experience in the biopharmaceutical industry or its equivalent.
Proven experience in validation and lifecycle management of quality systems.
Proven leadership skills and track record of success in managing technical projects and teams in a matrix environment
Excellent project management skills
A working understanding of lean principles and establishment of effective process metrics is preferred.
Excellent project management, communication, and technical writing skills are required.
Possess the professionalism and technical competency required to represent the department before stakeholders, regulatory agencies, and management.
Strong knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
Strong knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements particularly as it applies to biologics manufacturing.
Knowledge of Quality Risk Management principles.
Ability to develop and apply new and innovative approaches to projects and processes.
Understands business needs and synthesizes solutions across functions.
Must be able to influence others in matrix environment.
Provides technical expertise to peer, colleagues, and stakeholders .
Demonstrates ability to constructively lead and encourage peers and team members to drive results in a changing environment.


CONTACTS

Work both independently, in a team environment, or as a mentor/leader at all levels of the organization, in particular Digital Plant, Quality, and Validation.

WORKING CONDITIONS

Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.

DECISION MAKING

Take action, final decision, recommend

Exercises sound judgment in making decisions and recommendations. Routinely makes decisions and takes or influences action on typical and atypical cases. Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in analyzing problems and developing recommendations. Acts as an advisor to colleagues and becomes actively involved to meet schedules or resolve problems. Erroneous decisions or failure to achieve results will have significant financial implications, compliance implications or cause significant delays in schedules.

SUPERVISION RECEIVED

Works with minimal supervision on the accomplishment of agreed upon goals and objectives.

SUPERVISION EXERCISED

Individual contributor and/or oversight of full-time employees and contract workers.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527800_EN

Updated: 2020-07-21 00:00:00.000 UTC

Location: Syracuse,New York

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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