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Senior Quality Assurance Manager
hace 3 semanas
Precision for Medicine is seeking a highly skilled Senior Quality Assurance Manager to join its team. The ideal candidate will have extensive experience in clinical research with a focus on Quality Assurance and Compliance.
Key Responsibilities:
- Manage the audit program and support clinical projects to ensure compliance with regulations and company procedures.
- Develop and implement quality management systems, including standard operating procedures (SOPs), training, and corrective action plans (CAPAs).
- Collaborate with the Quality and Compliance staff and Operations team to provide strategic guidance and advice on compliance matters.
- Initiate follow-up actions when suspected scientific misconduct or serious non-compliance is identified.
- Audit regulatory documents for submission to the FDA and global regulatory authorities.
- Provide ICH/GCP guidance, auditing advice, and training to internal and external clients.
- Participate in the Management Team to counsel on and direct quality initiatives.
- Support Corporate Compliance functions and facilitate business development and proposals as needed.
- Lead system, site, documentation, and Trial Master File audits to ensure compliance with internal SOPs/project plans and industry standards.
- Review and audit documents intended for submission to the FDA to assure compliance with regulatory standards.
- Broaden the current QMS by establishing additional company standards and metrics to ensure high-quality services provided to clients.
- Maintain current knowledge of regulations and guidance documents, providing expert analysis to project teams.
Requirements:
- Bachelor's degree in a science, healthcare, or related field of study or equivalent.
- 10 years of experience in clinical research with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies.
- CRO, Pharmaceutical, and/or medical device experience.
- Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
- Ability to travel up to 30% domestically and/or internationally.
Preferred Skills:
- Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills.
- Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations, and company SOPs.
- Ability to review and evaluate clinical data, advanced proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database.
- Understands financial management to review proposals and budgets.
- Exhibits high self-motivation and ability to work independently as well as in a team environment.
- Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and keen attention to detail.
- Fluent in English language, with excellent verbal and written communications skills.
About Precision for Medicine
Precision for Medicine is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.
