Clinical Quality Assurance Manager - California, United States - Meet Recruitment

Description

We are partnering with a dynamic small biotech in the oncology space that is looking to expand their quality team with a Clinical Quality Assurance Manager.

As the Clinical Quality Assurance Manager, you will play a pivotal role in overseeing the quality assurance activities within our clinical operations.

You will be responsible for developing and implementing quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards.

Additionally, you will lead a team of quality assurance professionals to conduct audits, assess compliance, and drive continuous improvement initiatives.

Key Responsibilities:
Develop and implement quality assurance policies, procedures, and systems to ensure compliance with regulatory requirements and industry standards.
Lead and manage a team of quality assurance professionals, providing guidance, training, and support as needed.
Conduct internal audits and assessments to evaluate compliance with SOPs, protocols, and regulatory requirements.
Collaborate with cross-functional teams to identify quality issues, investigate root causes, and implement corrective and preventive actions.

Serve as the primary point of contact for regulatory inspections and audits, ensuring readiness and facilitating responses to regulatory authorities.

Drive continuous improvement initiatives to enhance the effectiveness and efficiency of quality assurance processes and systems.


Qualifications:
Bachelor's degree in a relevant scientific or healthcare discipline; advanced degree preferred.
Minimum of 4 years of experience in clinical quality assurance within the pharmaceutical, biotechnology, or medical device industry.

Strong knowledge of regulatory requirements and industry standards related to clinical trials (e.g., FDA, EMA, ICH-GCP).Proven experience leading quality assurance activities, including audits, inspections, and compliance assessments.

Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Detail-oriented with strong analytical and problem-solving abilities.
Certification in quality assurance (e.g., ASQ Certified Quality Auditor) is a plus.#J-18808-Ljbffr