Bristol Myers Squibb Manager, QC Technical Support (QC Services) in Devens, Massachusetts
MAJOR DUTIES AND RESONSIBILITIES:
Manage the QC Technical Support QC Services staff in developing and sustaining the following core programs: QC lab investigations, QC data trending, and QC training.
Direct investigation teams for medium and high risk QC investigations and CAPAs. Proactively manage progression and facilitate resolution of obstacles to ensure timely completion. Monitor and report progression to site management.
Manage projects and training initiatives, which directly support the site, to effectively implement strategic business objectives in driving quality, compliance, and effectiveness.
Lead the design of appropriate training and development delivery methods, the design of implementation plans, and the measurement of training effectiveness.
Drive the QC trending program, ensuring timely reporting of key metrics and trend analyses. Integrate QC data trending within quality and continuous improvement efforts.
Ensure cGMP compliance in all aspects of team operations.
Develop and implement lean processes for operational procedures.
Recruit and develop a high performing team with diverse backgrounds and talents. Coach and counsel team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.
Communicate and maintain performance metrics for her/his team, setting and maintaining high expectations for team performance.
Develop and drive staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns.
Provide technical guidance to QC and serves as area Subject Matter Expert in cross functional, cross departmental work teams.
Participate on a variety of network teams (technical/strategic) in support of business processes/ improvements.
Perform review of regulatory dossiers on as needed basis.
Identify and drive business improvement projects on site/network.
SME of the Quality System to understand impact of changes to these systems and their integration.
KNOWLEDGE AND SKILL:
Knowledge of science generally attained through studies resulting in a BS/MS in chemistry, molecular biology, or equivalent is required.
A minimum of 6 years (MS) / 8 years (BS) experience in biopharmaceutical quality with a minimum of 4 years of management responsibility.
Demonstrated skills in project management and structured problem solving techniques used to support QC investigations, CAPA, risk assessments.
Knowledge of data analysis and trending techniques (e.g., statistical process control).
Experience with lab training program design and curricula development preferred.
Knowledge of applicable business systems including Trackwise, LIMS, SAP, learning management systems (e.g., SucessFactors), and laboratory EDMS.
Knowledge of method validation transfer for biologics methodology.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Demonstrated experience with Lean/Six Sigma.
Extensive knowledge of US and EU cGMP regulations and guidance.
Experience with regulatory agency (FDA, EMEA, TGA) inspections required.
Incumbents have daily interaction with their subordinates and other members of the site Quality organization. This role has business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Automation, Technical Services, EHS and Manufacturing staff. Less frequent contact with general business functions including human resources, and Finance and BMS staff at other locations, including corporate headquarters. Occasional contact with outside vendors and contact with representatives from health authorities / regulatory agencies during site audits.
Work is largely performed in a modern office and a cGMP laboratory / manufacturing facility where one must maintain a high attention to detail and to be aware of the presence of workplace hazards including pressurized liquids gases, steam, biohazards and hazardous chemicals. The use of Personal Protective Equipment (PPE) will be required in the laboratories and in some portions of the facility.
Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment with in generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as an advisor to subordinate staff to resolve problems. Develops performance requirements and evaluates SMEs accordingly. Establishes and recommends changes to policies which affect subordinate organization. Develops a coaching and mentoring environment for subordinates that fosters open communication. Works with peers to ensure alignment of priorities and agreement of project ownership.
Receives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with establishes policies. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
SUPERVISION EXERCISED: Directly: 3 - 6 exempt; up to 3 non-exempt.
Travel Required: Up to 10%
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.