Clinical GMP QA Director of large biologics drug substance pilot facility in Gaithersburg MD. Leads the QA functions for "in plant" and laboratory activities related to drug substance manufacturing and testing. Additionally, manages a validation team.
Responsibilities may include the following: Auditing (internal and external - utilizing risk based strategy. Document systems. Change management utilizing a risk based approach. Operational Excellence utilizing tools such as DMAIC and root cause analysis. Quality at the source utilizing on the floor real time review of batch records. Electronic system utilizing tools such as Trackwise and SAP. Product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Assist QA Management to develop the department budget and analyze headcount requirements. Line management and staff supervision includes scheduling, recruiting and performance management. Approve SOPs, batch record and deviations. Organizing work systems. Strong time management skills. Writes and reviews regulatory submission documents to Board of Health. Host and manages Board of Health and 3rd party audits. Directors may travel internationally and interact with regulatory organizations. May be assigned to due diligence business meetings.
A. People manager - Drive results through direct reports: Ability to set clear expectations and priorities; structure and delegate work; and provide ongoing feedback and coaching for performance and development.
B. Enterprise leader - Drive results through organization and team: Ability to set and translate strategy into priorities for execution; build capability of function; and advance employee engagement, talent development/succession.
C. Auditing internal and external - Ability to host and lead audits both internal and external utilizing risk based strategy. Knowledge and use of standard industry audit tools.
D. Document systems management - Ability to manage quality document systems such as change control, non-conformance and CAPA systems.
E. Operational Excellence utilizing tools such as DMAIC and root cause analysis.
F. Managing "quality at the source" utilizing on the floor real time review and investigations.
G. Foster culture of teamwork and alignment.
H. Managing work and data utilizing electronic system tools such as Trackwise and SAP.
I. Managing product release utilizing systematic process flows.
J. Operating skills including timely decisions, managing and measuring work along with good overall time management.
K. Managing and measuring work through metrics along with good overall time management.
B.S. in Biology, Chemistry, Engineering or related fields. Masters or PhD preferred.
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...