Associate Director, Investigations - Devens, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

Devens, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

Take your career farther than you thought possible.

Position Summary
The Associate Director, Investigations, leads a team of investigators who perform root cause deviations within the Quality Management System. The Associate Director will champion continuous improvement activities to exceed investigation site metrics and reduce manufacturing defects. They will also make improvements to the processes for investigations, corrective and preventative actions, and product complaints. The Associate Director reports to the Sr. Director of site Manufacturing Sciences and Technology.

Responsibilities include, but are not limited to, the following:

Provides oversight of lead investigators
In partnership with Quality Assurance executes the investigations, CAPA, and product complaints programs.
Establishes and reports metrics for investigations and CAPAs. In collaboration with Quality Assurance, Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
Establish and maintain lead investigators certification training program
Performs review and approval of site and department SOPs.
Ensure safe and compliant cGMP operations and maintains permanent inspection readiness. Actively supports regulatory inspections.
Interact with other teams including Process Engineering and Manufacturing Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
Stay current with industry trends and BMS standards and participate in best practice forums consistent with function responsibilities.

Leadership:

Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
Defines and enforces performance measures, provides developmental feedback and coaching
Create an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments
Support organizational strategic goals and objectives that are linked to the overall company strategy
Champion continuous improvement, problem solving, and incident prevention initiatives
Drive strong collaboration within the Devens Cell Therapy Manufacturing plant and across the network
Deliver business results through timely and quality decision making and advice

REQUIRED COMPETENCIES:

Qualifications and Education Requirements:

Experience in leading investigations, performing root cause analysis and identifying corrective and preventative actions
Experience in building and growing an organization into a high performing team
Excellent verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Experience with Operational Excellence and Lean Manufacturing is a plus.
Proficient in cGMP's and multinational biopharmaceutical/cell therapy regulations
Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is required.
Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
A minimum of 10 years of experience in biopharmaceutical operations with 4+ years of prior management experience

WORKING CONDITIONS (US Only):

Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits,