Senior Quality Assurance Manager
5 days ago
Sharp Corporation is seeking an experienced Senior Quality Assurance Manager to join our team. As a key member of our QA department, you will be responsible for ensuring compliance with cGMP standards and regulations.
Job Description- Lead the development and implementation of quality systems and processes to ensure compliance with FDA and EU regulations.
- Oversee the review and approval of analytical lab documents, investigations, CAPAs, manufacturing, packaging, labels, and release of material.
- Provide leadership and oversight to analytical lab teams, ensuring adherence to SOPs and WRKIs.
- Develop and maintain KPIs for batch record review right first time and error tracking.
- Bachelor's degree in technical discipline (BS/BA) from a four-year college or university preferred with four to seven years related experience and/or training; or equivalent combination of education and experience.
- 4-7 years in pharmaceutical or biotech manufacturing in a Quality or Compliance role.
- Experience in analytical chemistry, compliance, and technical writing.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, and negotiate and meet critical timelines.
- Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
- Proficient with interpreting and implementing cGMPs, FDA & DEA Regulations, and CFRs.
- Leadership skill to mentor and develop team to achieve company goals.
This estimate is based on national averages and may vary depending on location and other factors.
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