Quality Assurance Manager
Synedgen, a pharmaceutical company in Southern California, is hiring a Quality Assurance (QA) manager. The QA manager is responsible for the day-to-day management of the company’s quality processes to ensure that implementation, maintenance, and improvement activities and documentation meet the appropriate quality and regulatory requirements. This is an excellent opportunity to join a small team in an expanding organization as it develops novel drug products with the potential to impact millions of lives.
- Develop, Implement, and Enhance the company’s quality and regulatory processes, including SOPs, policies, forms, and reporting tools.
- Oversee QA documentation system.
- Maintain quality system compliance with daily oversight of QA processes.
- Review of Manufacturing, QC, and non-clinical protocols, reports, and data.
- Responsible for review and approval of raw materials release, batch release, stability data, and batch disposition.
- Manage supplier qualification and audit program.
- Oversee key quality processes, including complaint, CAPA, deviations, training, and internal audit activities.
- Lead periodic management review to ensure management is informed about appropriate QA metrics, goals, and improvements.
- Manage and mentor quality assurance team.
- Flexible and adaptive, capable of applying principles creatively to a specific need and environment
- Demonstrated supervisory experience
- Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
- Excellent verbal and written communication skills
- Excellent analytical skills, highly organized, detail-oriented, quality and accuracy focused
- BS or BA in a scientific field
- At least 5+ years of Quality Assurance experience in the pharmaceutical or biopharmaceutical industry
- Working knowledge of GxP regulations and ICH Guidelines
- Experience working at small companies is a plus.
Applicant review begins immediately. Cover letter, resume or CV, and list of three references must be submitted below or sent to firstname.lastname@example.org
Local Candidates Preferred
An Equal Opportunity Employer