Manager Quality Systems, Investigations and CAPA - Devens, MA

Manager Quality Systems, Investigations And CapA - Devens, Ma

Attention Military Affiliated Job Seekers : Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps. This role is "On-Site" at the location detailed in the job post.

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. Take your career farther than you thought possible. 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.

Position Summary : The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities.

Duties / Responsibilities :

Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.

Ensure quality system deliverables are robust and adequately address requirements and risks, by providing oversight and rubric reviews, as applicable.

Support the administration and maintenance of quality systems such as CAPA, Investigations, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation, as needed.

Share data / knowledge within and across site and network.

Build & maintain strong relationships with partner functions.

Lead meetings and represent function at cross functional and network meetings.

Identify improvement opportunities and drive team continuous improvement goals and projects.

Support internal and external inspections.

May act as subject matter expert and present quality system program overviews and related topics during audits.

Maintain compliance with assigned learning plan.

Support integration of newer team members and provide guidance and coaching to users of the electronic QMS, CAPA, and Investigations quality systems, as required.

Reporting Relationship : This position is within the Devens Cell Therapy Compliance and Quality Systems Organization, reporting to the Director of Compliance and Quality Systems Management.

Minimum Education Required : High School / GED.

Job Category : Management.

Additional Qualifications / Responsibilities :

Specific Knowledge, Skills, Abilities : Ability to research, understand, interpret, and apply internal policies and regulatory guidelines. Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications. Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed change control actions. Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with quality risk management principles. Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy. Ability to work in a fast-paced team environment and changing priorities. Detail oriented and task focused with ability to meet deadlines and prioritize work. Able to independently work across and influence cross-functional groups to ensure requirements are met. Ability to motivate and foster a positive team environment. Confident in making decisions for complex issues and able to recognize Quality issues and solve problems. Curious and ability to think critically to create innovative solutions.

Education / Experience / Licenses / Certifications : Bachelor's degree in STEM field preferred. High school diploma / Associates degree with equivalent combination of education and work experience may be considered. 6+ years of experience in a regulated industry, preferably with 2+ year of quality system experience. Experience in FDA / EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Demonstrated proficiency with electronic system and databases.

The starting compensation for this job is a range from $115,110 - $139,500 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.