Senior Manager, ECQ Delivery

Bristol-Myers Squibb; Summit (NJ); On-site; USD 125,740 - 152,368; Full time

Benefits offered by this job

Health Coverage

Wellbeing programs

401(k) plan

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Equipment Commissioning & Qualification (ECQ) Delivery in Summit West, NJ. You will lead a large team responsible for commissioning and qualification of equipment, facilities and computerized systems across multiple projects, ensuring on-time, within-budget delivery.

The role requires BS in engineering or science, 7+ years in pharma validation and project leadership, strong cGMP knowledge, and ability to interact with regulators.

Qualifications

• BS in Engineering or Science related discipline required.
• Minimum of 7 years experience performing/supporting pharmaceutical validation in a GMP environment.
• Minimum of 7 years experience managing personnel and projects.
• Experience interacting with regulatory agents/auditors in a compliance environment.
• Thorough knowledge of cGMP in the pharmaceutical industry and computer systems validation.

Responsibilities

• Directly manage Equipment Commissioning & Qualification, qualification and CSV teams.
• Define needs, benefits and technical strategy within the project lifecycle.
• Oversee SOPs, test protocols, validation deliverables, and policies.
• Lead a team of up to 50 across multiple areas and supervise staff.
• Ensure compliance with regulatory requirements and conduct audits as SME.
• Provide customer service/support and technical guidance on qualification issues.

Skills

cGMP knowledge

GXP knowledge

SDLC

Regulatory audits

Leadership

Financial acumen

Project management

Deviations & CAPA

Written & verbal communication

Interpersonal skills

Education

BS in Engineering or Science

Tools

CMMS

Microsoft Office Suite

Job description

Bristol Myers Squibb is seeking a Senior Manager, Equipment Commissioning & Qualification (ECQ) Delivery in Summit West, NJ. You will lead a large team responsible for commissioning and qualification of equipment, facilities and computerized systems across multiple projects, ensuring on-time, within-budget delivery.

The role requires BS in engineering or science, 7+ years in pharma validation and project leadership, strong cGMP knowledge, and ability to interact with regulators.