Bristol Myers Squibb

Pharmaceuticals

Manager,LabelOperations

$104–125k Summit, New Jersey, United States FULL TIME Remote Friendly
The Brief

“Manager, Label Operations at Bristol Myers Squibb. Skills: Label Operations, GMP, Quality Management. Implement and manage site Label Operations. Supervise all label control activities”

What You'll Achieve.

Achieve quality policies; Achieve quality objectives

Industry & Context.

Pharmaceuticals
Problems you'll solve

Problem solving; Conflict management; Troubleshooting

Eligibility Requirements

Sunday - Wednesday, Night Shift, 6 p.m. - 4:30 a.m.

What They're Looking For.

Must Have

Advanced GMP knowledge, Advanced Quality knowledge, Advanced compliance knowledge, Advanced risk management knowledge, Interpret problems and prepare communication, Provide guidance on compliance, Provide guidance on technical issues, Develop employees, Coach employees, Critically review reports, Provide input on Quality Risk management, Action-oriented, Customer-focused, Skilled in decision-making, Skilled in building relationships, Skilled in problem solving, Skilled in conflict management, Skilled in planning, Skilled in organizing, Skilled in resource allocation, Skilled in analytical thinking, Skilled in coaching others, Skilled in talent selection, Skilled in developing others, Skilled in innovation management, Independent mindset, Tenacity, Lead teams, Lead cross-functional project teams, Drive team performance, Drive team results, Contribute to departmental performance, Contribute to departmental quality, Conceptualize impact of quality initiatives

What You'll Do.

Implement and manage site Label Operations

Supervise all label control activities

Develop and maintain GMP compliant label process

Establish label control process

Maintain label control process

Improve label control process

Ensure patient safety

Ensure regulatory requirements

Improve effectiveness

Lead team for Label Management

Align with Global Regulatory requirements

Align with Regional Regulatory requirements

Motivate team members

Cultivate collaborative environment

Oversee team responsibilities

Maintain state of compliance

Identify label control compliance issues

Address label control compliance issues

Oversee daily activities

Supervise daily activities

Coordinate daily activities

Prioritize daily activities

Act as site lead for system implementation

Support projects within timelines

Assure job objectives are met

Assure timely issuance of labels

Coordinate project deliverables

Prioritize project deliverables

Create employee development plans

Oversee functional area for staffing

Assure adequate staffing

Provide support for electronic label systems

Write standard operating procedures

Review standard operating procedures

Update standard operating procedures

Manage archival of batch records

Manage archival of GMP documentation

Perform gap assessments

Identify process deficiencies

Provide reports on findings

Recommend potential solutions

Develop quality metrics

Maintain quality metrics

Collaborate with stakeholders

Develop actions to resolve issues

Develop requirement for new staff

Manage requirement for new staff

Maintain current knowledge of industry standards

Perform supplemental investigations

Perform supplemental projects

How You'll Work.

Team & Collaboration

Cross-functional project teams

Communication Scope

Clarity; Brevity; Accuracy

Process & Methodology

Project timelines, Project deliverables

Free ATS check

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