Manager, QA Clinical Manufacturing Ops
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Devens facility currently has an opening in our Quality Assurance group for a Manager, QA Clinical Manufacturing Operations.
Duties/
Responsibilities:
Provides QA oversight in the startup of the Devens Clinical Manufacturing Building, including both the qualification/validation of the facility and the review and approval of phase-appropriate SOPs.
Supervises and executes operating procedures for the Quality Assurance program which assures clinical material release.
Ensures all release packages are completed in accordance with SOPs for Quality Management signatory.
Responsibilities include updates to Drug Substance lot status in applicable quality systems.
Provides supervision to QA personnel supporting clinical manufacturing activities on a day to day basis and provides oversight of the review and approval of master and executed batch records in the Clinical Manufacturing Facility.
Performs review and approval for documents such as specifications and SOPs intended to support the ongoing compliant operation of the Clinical Manufacturing Facility, utilizing phase-appropriate approaches that are aligned with Devens site practices and BMS policies and directives.
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.
Directly participates in internal audits or reviews as well as global health authority inspections.
May include representation on inspection response and CAPA teams.
Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.
Establish and communicates performance objectives for Quality Assurance staff that are consistent with the businesses unit goals, Quality and Global Manufacturing and Supply objectives.
Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
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.
Qualifications 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 experience in biopharmaceutical quality with a minimum of 2 years of management responsibility.
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, TrackWise, and electronic batch recording systems, is desirable.
Microsoft Office suite knowledge and proficiency with Excel is desirable.
Strong background and demonstrated effectiveness in phase-appropriate quality systems to support clinical manufacturing operations and understanding of clinical biologics manufacturing.
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 organization skills.
Experience working in a team based environment and collaborating with other departments and senior leadership.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502069.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Devens facility currently has an opening in our Quality Assurance group for a Manager, QA Clinical Manufacturing Operations.
Duties/
Responsibilities:
Provides QA oversight in the startup of the Devens Clinical Manufacturing Building, including both the qualification/validation of the facility and the review and approval of phase-appropriate SOPs.
Supervises and executes operating procedures for the Quality Assurance program which assures clinical material release.
Ensures all release packages are completed in accordance with SOPs for Quality Management signatory.
Responsibilities include updates to Drug Substance lot status in applicable quality systems.
Provides supervision to QA personnel supporting clinical manufacturing activities on a day to day basis and provides oversight of the review and approval of master and executed batch records in the Clinical Manufacturing Facility.
Performs review and approval for documents such as specifications and SOPs intended to support the ongoing compliant operation of the Clinical Manufacturing Facility, utilizing phase-appropriate approaches that are aligned with Devens site practices and BMS policies and directives.
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.
Directly participates in internal audits or reviews as well as global health authority inspections.
May include representation on inspection response and CAPA teams.
Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.
Establish and communicates performance objectives for Quality Assurance staff that are consistent with the businesses unit goals, Quality and Global Manufacturing and Supply objectives.
Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
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.
Qualifications 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 experience in biopharmaceutical quality with a minimum of 2 years of management responsibility.
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, TrackWise, and electronic batch recording systems, is desirable.
Microsoft Office suite knowledge and proficiency with Excel is desirable.
Strong background and demonstrated effectiveness in phase-appropriate quality systems to support clinical manufacturing operations and understanding of clinical biologics manufacturing.
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 organization skills.
Experience working in a team based environment and collaborating with other departments and senior leadership.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502069.
Estimated Salary: $20 to $28 per hour based on qualifications.
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