|| Quality Assurance Director
||Vice President of Quality
This position is responsible for Quality Assurance Manufacturing Operations, Operational Support, Documentation Control / Quality Release functions and Commercial Manufacturing related Quality Systems for In-Process operations sampling/auditing support.
- Provides cGMP commercial manufacturing facility compliance support: Development, Validation, Maintenance, In-Process QA auditing-sampling of Product, component Material Release functions/activities
- Provides QA support of the following teams/processes: Development, Validation, Maintenance, training, Document Management Systems, ongoing routine manufacturing audit-sampling support, general QA support of the Plant Quality Systems and/or compliance auditing activity. Reporting, tracking and follow-up of deficiencies / CAPAs noted.
- Oversees and manage / maintain the cGMP manufacturing and/or manufacturing related documentation and ensure its integrity for executed Quality Records and document retention
- Participates in and/or manage the Operational and/or Operations related Quality Systems Improvement Projects as assigned;
- Works directly with Amerigen departmental peers, QA team members, with monitoring/follow-up and facilitation of CAPA and CAPA related action items pertaining to cGMP compliance quality problem investigations. Work with and support operational team members in facilitation / monitoring status with timely processing on CAPA action item activity to closure. (for all operations compliance / related activity);
- Be responsible for the QA operations cGMP compliance training. Support operations and operational support groups/teams. Overall QA team mentoring and member development.
- Assists management with participation in on-site regulatory agency and/or compliance audits.
- Other related duties as assigned by supervisor.
|Desired Skills & Experience
- Bachelor or above in Pharmaceutical or Chemical;
- At least 10 years solid working knowledge and work experience in quality management in a USFDA cGMP Manufacturing Pharmaceutical environment.
- Experience in the management of, development of and motivation of a multi-level-skilled QA Team functioning in a Team Based environment.
- Strong compliance leadership and team mentoring skills, Strong ability in building consensus and help to influence compliance and compliance related decisions, ability to effectively plan – organize and communicate improvement initiatives / ideas in a dynamic cross-functional environment.
- Solid problem solving skills. (i.e., ability to Compile, Analyze,
- Recommend and execute appropriate CAPA initiatives.
- Strong Time Management and Organizational skills.
- Strong Communication Skills in both written and verbal.
- Fluent in English.