Senior Director, GCP/GLP Quality Assurance - Apex Systems

Job#: 2057513

Job Description:

Senior Director, GCP/GLP Quality Assurance 2057513
Location:Watertown MA (Onsite)
Science/Focus:Immunological Diseases
Job Overview:This role will lead the Clinical Quality strategy, aligning with regulatory standards, managing quality programs and audits, and providing compliance guidance for clinical and non-clinical development.
Primary Job Responsibilities:

• Develop a Clinical Quality strategy aligning with organizational goals and regulatory standards.

• Implement a targeted audit strategy for clinical and non-clinical studies.

• Provide expert compliance advice within clinical study teams for quality improvement.

• Evaluate and select service providers, securing Quality Agreements for compliance.

Primary Job Requirements:

• Bachelors degree in life sciences with over 15 years in the biopharmaceutical field.

• Knowledgeable in FDA, EU, and ICH regulations, especially in early-phase trials.

• Experienced in managing GCP inspections; BIMO inspection experience preferred.

• Strong at building cross-functional partnerships to meet strategic goals.

• Proficient in critical thinking, CRO operations, and clinical trial systems.

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 [email protected] or 844-463-6178.