Senior Manager/ Associate Director Quality Assurance (GCP) 1360908

Location: Greater Boston, MA (Remote)

Science/ Focus: Small Molecule

Job Overview: Lead the develop the clinical QA function by implementing a quality system that supports the compliance of ICH, GCP, GLP and other global regulatory requirements.

Responsibilities:

• Develop and implement risk management processes, and SOPs for internal and external oversight
• Oversee QA review and approval of clinical study reports, ICFs, external publications, and regulatory submissions
• Implement an early-stage clinical site quality audit program in collaboration with clinical study teams.
• Lead the nonclinical and clinical vendor, and internal quality audit programs.
• Ensure the nonclinical and clinical sites are audit ready and compliant
• Develop and conduct training

Requirements:

• BS/MS with 6+ years of experience in pharma/ biotech with significant experience in GCP
• Experienced with nonclinical and clinical studies including CRO oversight is ideal
• Previous exposure in GLP/GCLP is an added plus
• Able to travel as needed for audits

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.

jditalia@stratacuity.com

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@apexsystems.com or 844-463-6178.