Vertex Pharmaceuticals
Senior Manager, GMP Operational Quality Cell and Gene (On-site)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job DescriptionGeneral Summary:
The Operational Quality Senior Manager Cell and Gene is recognized as an expert internally in the principles and application of quality assurance and compliance. The Operational Quality Senior Manager Cell and Gene coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Operational Quality Senior Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
KEY RESPONSIBILITIES:
As part of the Quality Operations group primarily responsible for providing quality oversight and support to operations at the Vertex CPI and Drug Product Facility in the following key areas/activities, support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.
In process and Drug Product Release:
Accountable and Responsible for the clinical batch disposition. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Accountable and responsible for approval of CPI and Drug product clinical lot.
Accountable and responsible for archival of batch records and other supporting documents in Veeva QMS.
Responsible for monitoring and tracking performance metrics, trends; including site metrics for disposition.
Compliance Oversight of Internal Operations - QA Operations and Compliance:
Provide production floor support and guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including packaging and shipment.
Review and approval of Manufacturing documents e.g. MBR, APSs etc.
Provide QA support of development change controls, GMP investigations, associated CAPAs and Effectiveness Checks.
Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement.
Responsible for identifying risks and communicating gaps for GMP process/systems.
People and Performance Management:
Responsible for Talent Acquisition/Recruiting/Interviewing/Selection/Onboarding.
Performance Management (goals, monitoring, reviews).
Monitoring / Supporting Employee Engagement and Retention.
Succession Planning.
Accountable to provide oversight of day-to-day operations.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIESKey Leadership Skills:
Cross-functional collaborator.
Results Driver.
Key Knowledge/Skills and Competencies:
Strong leadership skills with the ability to thrive in a high throughput environment.
Project Management / Continuous Improvement.
Ability to lead and manage complex projects/teams within corporate objectives and project timelines.
Proficiency utilizing project management processes/tools to lead meetings, assist with project planning, and facilitate completion of tasks.
Collaboration / Teamwork / Conflict Management.
Ability to independently lead cross-functional teams and represent the Quality unit.
Communication/Coaching / Influencing.
Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff.
Ability to effectively influence others within technical area of expertise.
Ability to communicate effectively across all organizational levels.
Critical Thinking / Problem Solving.
Ability to evaluate quality matters and make decisions utilizing risk-based approach.
Flexibility/Adaptability.
Attention to detail.
Knowledge in the following areas:
Expert knowledge of global GMP requirements governing VCGT drug products and knowledge of VCGT manufacturing practices.
Proven experience supporting GMP manufacturing either via experience in manufacturing and/or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role.
Demonstrated ability to work independently to provide QA support.
REQUIRED EDUCATION AND EXPERIENCE:
Demonstrated success independently leading cross-functional teams.
Experience providing QA support and oversight of GMP manufacturing operation including batch release.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
M.S (or equivalent degree) and 2-3 years of relevant work experience, or B.S in scientific or allied health field (or equivalent degree) and 7+ years of relevant work experience.
On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Company Information: Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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The Operational Quality Senior Manager Cell and Gene is recognized as an expert internally in the principles and application of quality assurance and compliance. The Operational Quality Senior Manager Cell and Gene coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Operational Quality Senior Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
KEY RESPONSIBILITIES:
As part of the Quality Operations group primarily responsible for providing quality oversight and support to operations at the Vertex CPI and Drug Product Facility in the following key areas/activities, support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.
In process and Drug Product Release:
Accountable and Responsible for the clinical batch disposition. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Accountable and responsible for approval of CPI and Drug product clinical lot.
Accountable and responsible for archival of batch records and other supporting documents in Veeva QMS.
Responsible for monitoring and tracking performance metrics, trends; including site metrics for disposition.
Compliance Oversight of Internal Operations - QA Operations and Compliance:
Provide production floor support and guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including packaging and shipment.
Review and approval of Manufacturing documents e.g. MBR, APSs etc.
Provide QA support of development change controls, GMP investigations, associated CAPAs and Effectiveness Checks.
Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement.
Responsible for identifying risks and communicating gaps for GMP process/systems.
People and Performance Management:
Responsible for Talent Acquisition/Recruiting/Interviewing/Selection/Onboarding.
Performance Management (goals, monitoring, reviews).
Monitoring / Supporting Employee Engagement and Retention.
Succession Planning.
Accountable to provide oversight of day-to-day operations.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIESKey Leadership Skills:
Cross-functional collaborator.
Results Driver.
Key Knowledge/Skills and Competencies:
Strong leadership skills with the ability to thrive in a high throughput environment.
Project Management / Continuous Improvement.
Ability to lead and manage complex projects/teams within corporate objectives and project timelines.
Proficiency utilizing project management processes/tools to lead meetings, assist with project planning, and facilitate completion of tasks.
Collaboration / Teamwork / Conflict Management.
Ability to independently lead cross-functional teams and represent the Quality unit.
Communication/Coaching / Influencing.
Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff.
Ability to effectively influence others within technical area of expertise.
Ability to communicate effectively across all organizational levels.
Critical Thinking / Problem Solving.
Ability to evaluate quality matters and make decisions utilizing risk-based approach.
Flexibility/Adaptability.
Attention to detail.
Knowledge in the following areas:
Expert knowledge of global GMP requirements governing VCGT drug products and knowledge of VCGT manufacturing practices.
Proven experience supporting GMP manufacturing either via experience in manufacturing and/or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role.
Demonstrated ability to work independently to provide QA support.
REQUIRED EDUCATION AND EXPERIENCE:
Demonstrated success independently leading cross-functional teams.
Experience providing QA support and oversight of GMP manufacturing operation including batch release.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
M.S (or equivalent degree) and 2-3 years of relevant work experience, or B.S in scientific or allied health field (or equivalent degree) and 7+ years of relevant work experience.
On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Company Information: Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
#J-18808-Ljbffr