* Position will provide support to the Supplier Quality Management Program for the business. Responsible for monitoring Supplier Quality and working closely with the Supplier on a variety of activities.
* Plan and maintain an overall audit schedule of the sites' suppliers based on appropriate risk assessment and qualification process.
* Manage and provide guidance and/or assist in defining, implementing and follow-up for supplier audit reports and CAPA ensuring adequate corrective action is in place and monitoring the effectiveness of that action.
* Development of a Supplier Quality management performance evaluation through Key Performance Indicators (KPI) and continuous improvement for the highest effectiveness of the supplier management system.
* Contribute to the development, maintenance and improvements of supplier management policies, standards and procedures.
* Participate in supplier development projects and continuous improvement activities focusing on supplier quality.
* Assist in Internal audits and ISO/FDA audits.
* Responsible for SAP Quality Module implementation (QM Views, inspection plans, Quality info records).
* Responsible for overseeing Supplier related changes and implementation of required actions to address changes.
* Responsible for tracking Supplier quality on a monthly / quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions.
* Communicate to management quality and regulatory issues on a timely basis.
* Assist with development of the Approved Supplier List and areas to be targeted during the assessment or evaluation.
* Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits.
Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
Excellent oral and written communication skills
Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
Strong problem solving skills
Strong negotiating/influencing skills
Ability to work independently under his/her own initiative
Ability to travel nationally and internationally as required approximately 40% of their time
At the highest level, demonstrated leadership capability and organizational skills
BS Chemistry, Life Sciences or Engineering required
Master's Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field desired
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.