Senior Manager, QA

Job Description

The position manages key QA functions for the clinical bulk manufacturing operations along with 3rd party contract manufacturing and testing operations.
Responsibilities and experience may include the following: Auditing (internal and external) utilizing risk based strategy. Change management utilizing a risk based approach. Management of the site's non-conformance and CAPA systems. Lead Gaithersburg's supplier qualification and raw material program. Apply Operational Excellence utilizing tools such as DMAIC and root cause analysis. Electronic system utilizing tools such as Trackwise, Aegis and SAP. Representing QA in several CMC project teams. Project related contract management. Managing/perform training to QA and related functions. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures. 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 records and deviations. Organizing work systems. Strong time management skills. Writes and reviews regulatory submission documents to Board of Health. Sr. Managers may travel internationally and interact with regulatory organizations. May be assigned to due diligence business meetings.
Performance Requirements

Essential Job Functions:

A. GMP auditing internal and external - utilizing risk based strategy.

B. Lead change management system - utilizing a risk based approach.

C. Manage site non-conformance and CAPA programs.

D. Lead site supplier qualification program.

E. Manage site raw material program.

F. Operational Excellence utilizing tools such as DMAIC and root cause analysis.

G. Manage work and data utilizing electronic system tools such as Trackwise, Aegis and SAP.

H. Lead for several clinical projects representing QA in CMC teams.

I. Manage project related activities at contractors.

J. Managing/perform training to QA and related support functions.

K. Line management and staff supervision includes scheduling, recruiting and performance management.

L. Operating skills including timely decisions, managing and measuring work along with good overall time management.

M. Develop staff and set priorities.

N. Managing and measuring work through metrics along with good overall time management.

Additional Job Functions:

A. Independently identify and resolve complex problems through good decision quality utilizing functional and technical skills. Manage conflict and stand alone on issues. Ability to confront direct reports.

B. Proven track record in developing or leading teams. Work on teams. Ability to lead
multiple teams within and outside the organization. Ability to work as a team member. Ability to work collaboratively with strong listening skills.

C. Ability to take strategic initiatives and translate into tactical solutions. Ability to initiate and develop strategic initiatives. Ability to develop strategy and negotiate senior management approval. Implementation of strategy is through staff.

D. Able to professionally communicate verbally, in writing and represent the function effectively. Good listening skills, interpersonal savvy, and peer relations. Ability to effectively present complex data and strategy to large groups.

B.S. in Biology, Chemistry, Engineering or related fields.

MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

My company shares my passion for helping to improve human health around the world.

""This is My MedImmune""

Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.


MedImmune, LLC.

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