Manager, Quality Assurance Lab Operations

Location: Devens

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. 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. Read more:

PRINCIPAL OBJECTIVE OF THE POSITION:

Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records and/or corrective actions that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Major Duties and Responsibilities

* Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business' unit goals, Quality and Technical Operations objectives.

* Provide quality floor support of complex manufacturing issues

* Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.

* Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.

* Provides quality oversight of manufacturing activities on a day-to-day basis and provides oversight of the review and approval of minor changes to master batch recipe records.

* Performs review and approval of Quality, Manufacturing, and Material Specification SOPs and documents.

* Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures.

* Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.

* Reviews, approves and provides guidance for quality master data. Responsibilities include updates to Drug Substance lot status in applicable quality systems.

* Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.

* May provide Quality review and approval of investigation records and CAPA, records.

* Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.

* May act as delegate for QA Operations Manager for departmental meetings, projects and tasks.

Major Duties and Responsibilities

* Key Core behavioral indicators for this role include participation in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.

* Demonstrates appropriate examples of compliance behaviors and attitudes.

Knowledge and Skill

* Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

* Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.

* Knowledge of US and EU cGMP regulations and guidance.

* Knowledge of electronic systems including any of the following: SAP, LIMS, QMS, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.

* Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.

* Knowledge and proven experience in FDA, EMA, or other regulatory authority.

* Knowledge in Operational Excellence and Continuous Improvement is desirable.

* Experience in building and growing an organization into a high-performance team.

* Demonstrated leadership, interpersonal, communication, and motivation skills.

* Excellent writing and oral communication skills are required.

* Previous work responsibility, which required a high degree of attention to detail.

* Well-practiced in exercising sound judgment in decision-making.

* Demonstrated multitasking and…