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Director/Senior Director Quality Assurance

Company: The American College of Radiation Oncology
Location: Waltham
Posted on: September 12, 2020

Job Description:

Director/Senior Director, Quality Assurance Waltham, MA

Director, Quality Assurance 1080298

Job Scope and Purpose:

Our Greater Boston area cell therapy organization is looking for a Director-level candidate to lead its Quality Assurance function in a newly created role. This hire will build and manage our client's Quality Management System for internal and virtual operations. The ideal candidate will have a strong background in clinical stage Quality for cell therapy and gene therapy (or orphan drugs), be a strong problem solver energized by a fast-paced, lean and agile environment, and a team player who can foster productive relationships with internal colleagues and with external partners.

Sound like you? Reach out to Todd Jamison to learn more today.

Primary Job Responsibilities:

Build and manage the Quality Assurance function supporting both virtual and in-house Cell Therapy GMP operations

Collaborate with QC and Manufacturing to manage internal and external GMP operations

Collaborate with Pre-Clinical and Clinical development to manage GxP operations

Provide strategic leadership to the Quality operations group with a continuous focus on improvement

Coordinate and execute periodic Quality Management Reviews and trend analysis of all aspects of cGMP operations

Build a risk management plan to support manufacturing and clinical activities

Negotiate and maintain Quality Agreements

Remain current on regulatory authorities' programs, guidance documents and activities in areas relevant to testing of cell therapy products

Manage audits and inspections

Evaluate the Regulatory Strategy for compliance with internal source documents

Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate

Ensures the company is in a constant state of inspection readiness across all functions through continuous education, training, and internal audits

Transition the Quality Management System from early stage to late stage and/or commercial

Primary Job Requirements:

Bachelor’s degree in a scientific or related field (or equivalent degree) plus 15+ years of relevant work experience, or Master’s degree and 8-10 years of relevant work experience

Experience with clinical stage Quality management of Cell and Gene Therapy products is a strong plus

Comprehensive knowledge of domestic and international GCP and GMP regulations

Experience working with Contracted Organizations and management of a manufacturing site

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

Apex Systems dba Stratacuity, is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Keywords: The American College of Radiation Oncology, Waltham , Director/Senior Director Quality Assurance, Other , Waltham, Massachusetts

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