Quality Assurance Manager
The Quality Assurance Manager will provide quality oversight within the Quality System, including but not limited to the development and review of SOPs, protocols, reports, data and records generated to support the qualification, distribution and disposition of product. Will conduct timely quality review of associated data, including data utilized to support batch release, to meet business and operation requirements.
The Quality Assurance Manager will have a minimum 5 years related experience in process improvement, analyzing information, strategic planning, verbal communication, informing others, emphasizing excellence, attention to detail, thoroughness, dealing with complexity and/or training and qualified to lead and manage all aspects of the quality control process.
Essential Duties and Responsibilities
- Routine quality review of CMO Partner’s documentation including batch record review for compliance to facilitate timely release of product lots.
- Quality Systems: Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, QA holds, Deviations, Technical Complaints/Adverse Events, Management Monitoring and Self inspection auditing, QA reporting and approval of GMP documentation.
- Quality Operations: Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely disposition of product lots.
- Reviews records to ensure data meets the industry requirements for data integrity.
- Provides Quality oversight over systems and process qualification, calibration and validation.
- Ensures that procedures are established and being followed as outlined under FDA, ISO, USP and GMP guidelines.
- Provides input and quality oversight over investigations, which includes review of investigation reports.
- Coordinates and implements centralized processes and ensures compliance to industry standards and compendia requirements.
- Establishes and maintains document and records controls.
- Conducts internal audits to determine if work activities affecting quality are in compliance with established quality procedures and that the quality management system is operating effectively.
- Initiates, follows up, documents, reviews, and files corrective action reports/deviation reports and implements corrective actions when procedures are not followed.
- Qualifies and approves Suppliers and subcontractors.
- Promotes a quality mindset and quality excellence approach to all activities.
Minimum Qualifications (Knowledge, Skills, and Abilities)
Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality experience in the pharmaceutical industry.
Minimum of 2 years’ experience in a supervisory role.
Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.
Must be flexible, and able to work in a small, fast-paced, dynamic, environment.
Ability to work autonomously within established guidelines, procedures and practices.
Committed to delivering high quality results, overcoming challenges and focusing on what matters.
Continuously looking for opportunities to learn, build skills and share learning.