Head of Quality, Cell Therapy Manufacturing, Raritan
Johnson & Johnson is recruiting for the Head of Quality, Cell Therapy Manufacturing based in Raritan, New Jersey.
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress.
As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good.
We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
We are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more atwww.
janssen.
comand follow us @JanssenGlobal.
The CAR-T Quality team at Janssen manages all aspects of Quality (QA/QC) in support of the Raritan, NJ based CAR-T Janssen Supply Chain (JSC) site, in compliance with established cGMP and J&J requirements.
The Sr.
Director, Site Quality Head of Cell Therapy Manufacturing Operations leads and manages all aspects of Quality functions for Raritan CAR-T JSC.
Activities include Quality Control testing, Quality Assurance review and approval functions, Validation (execution, review, and approval) functions, Compliance activities, Product Release activities, etc.
This Executive develops and implements long-term strategies, execution of Quality programs, and manages a team of people leaders and technical professionals within the QA/QC departments based on assigned work, direction, coaching and developing capabilities.
Major
Responsibilities:
Responsible for overall Quality oversight of cGMP operations (clinical and commercial manufacturing) at the Raritan Cell Therapy manufacturing facility, ensuring adherence to applicable GMP regulations and J&J policies and procedures.
As a member of the Advanced Therapies Quality Leadership team (ATQLT), partners with other JSC Site Quality Heads, and ensures harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.
Actively participates as a member of the Raritan Site Leadership Team, partnering with the Site General Manager, Legend counterparts, and CAR-T Senior Leaders.
Assures the required processes, procedures, systems, and resources are in place to ensure a compliant manufacturing, testing, and distribution process.
Collaborates with other Leaders across the organization to assist in the continuous improvement and lifecycle management of GMP policies and the Quality Management System.
Provides leadership and builds an exceptional team to manage the Quality functions, including hiring, mentoring, and developing.
Leads the site management review of Quality compliance and operational KPIs at the manufacturing facility; ensures timely mitigation of unfavorable trends.
Provides expertise and guidance in interpreting governmental/health authority regulations, agency guidelines and internal procedures to assure continued compliance.
Leads and hosts compliance audits including internal audits and regulatory inspections (e.
g.
, FDA, IGJ, etc.
).
Proactively develops and sustains strong relationships with regulatory authorities.
Analyzes regulatory authorities' programs and activities in areas relevant to cell therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
Develops departmental goals and ensure timely completion of all deliverables.
Champions and fosters a positive quality compliance culture, and diverse and inclusive workplace.
Represents the Raritan Cell Therapy Quality in the development, planning and execution of corporate initiatives.
Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to turnaround time and COGS improvement.
Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
Manages team of senior leaders and professionals within Quality.
Hires and develops employees within Quality team.
Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
Performs tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Recommended Skills Agility Auditing Business Process Improvement Business Processes Clinical Works Financial Management Estimated Salary: $20 to $28 per hour based on qualifications.
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress.
As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good.
We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
We are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more atwww.
janssen.
comand follow us @JanssenGlobal.
The CAR-T Quality team at Janssen manages all aspects of Quality (QA/QC) in support of the Raritan, NJ based CAR-T Janssen Supply Chain (JSC) site, in compliance with established cGMP and J&J requirements.
The Sr.
Director, Site Quality Head of Cell Therapy Manufacturing Operations leads and manages all aspects of Quality functions for Raritan CAR-T JSC.
Activities include Quality Control testing, Quality Assurance review and approval functions, Validation (execution, review, and approval) functions, Compliance activities, Product Release activities, etc.
This Executive develops and implements long-term strategies, execution of Quality programs, and manages a team of people leaders and technical professionals within the QA/QC departments based on assigned work, direction, coaching and developing capabilities.
Major
Responsibilities:
Responsible for overall Quality oversight of cGMP operations (clinical and commercial manufacturing) at the Raritan Cell Therapy manufacturing facility, ensuring adherence to applicable GMP regulations and J&J policies and procedures.
As a member of the Advanced Therapies Quality Leadership team (ATQLT), partners with other JSC Site Quality Heads, and ensures harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.
Actively participates as a member of the Raritan Site Leadership Team, partnering with the Site General Manager, Legend counterparts, and CAR-T Senior Leaders.
Assures the required processes, procedures, systems, and resources are in place to ensure a compliant manufacturing, testing, and distribution process.
Collaborates with other Leaders across the organization to assist in the continuous improvement and lifecycle management of GMP policies and the Quality Management System.
Provides leadership and builds an exceptional team to manage the Quality functions, including hiring, mentoring, and developing.
Leads the site management review of Quality compliance and operational KPIs at the manufacturing facility; ensures timely mitigation of unfavorable trends.
Provides expertise and guidance in interpreting governmental/health authority regulations, agency guidelines and internal procedures to assure continued compliance.
Leads and hosts compliance audits including internal audits and regulatory inspections (e.
g.
, FDA, IGJ, etc.
).
Proactively develops and sustains strong relationships with regulatory authorities.
Analyzes regulatory authorities' programs and activities in areas relevant to cell therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
Develops departmental goals and ensure timely completion of all deliverables.
Champions and fosters a positive quality compliance culture, and diverse and inclusive workplace.
Represents the Raritan Cell Therapy Quality in the development, planning and execution of corporate initiatives.
Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to turnaround time and COGS improvement.
Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
Manages team of senior leaders and professionals within Quality.
Hires and develops employees within Quality team.
Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
Performs tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Recommended Skills Agility Auditing Business Process Improvement Business Processes Clinical Works Financial Management Estimated Salary: $20 to $28 per hour based on qualifications.
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