Location:Frederick, United StatesJob reference:
Sep. 26, 2016
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions -- join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Supervisor - Supplier Quality in Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
You will provide leadership and guidance to a number of functional areas including manufacturing, facilities, and other quality departments, and may support manufacturing operations at contract facilities. Interpret and implement quality policies, manages quality systems, and assist in facilitating regulatory compliance inspections. You will supervise Quality Assurance Supplier Quality Specialists. You will establish, manage and deploy Supplier Quality Systems as related to creations, review and approval of vendor's files, review of Approved Vendor Lists for GMP direct / indirect materials. Following the Corporate Supplier Quality Audit Plan, CAPA review. Include execution of Supplier Initiated Changes, update of specifications. Key involvement in managing, delegating and achieving key projects for implementation and sustainability of quality systems as defined by MedImmune / Astra Zeneca corporate policies and standards. Work strongly with stakeholders in Procurement, Raw Materials, Manufacturing, Planning and Quality Systems & Compliance among others. Support the establishment of Quality Technical Agreements with vendors, sites and business partners. Build Supply Chain Assurance for robust systems.
* Bachelor's Degree with seven or more years of experience
* Supervises the Supplier QA staff that supports vendor management.
* Manages hiring, performance reviews, and employee development plans.
* Maintains oversight of daily operations within the manufacturing and facilities departments at FMC.
* Maintains Supplier Quality in a state of compliance with current good manufacturing practice regulations.
* Supports non-conformances for Supplier Quality for products and processes. Implements change controls within site according to SOPs in consulting with Quality and Regulatory Affairs.
* Investigates, assesses the impact of, and resolves minor, major and critical deviations that may occur during manufacture, testing, or distribution of products, or during the administration of quality systems. Identifies root causes, recommends and implements corrective and preventative actions.
* Maintains Approved Vendor List for GMP Materials
* Participates as a technical expert in audits of quality and manufacturing operations at FMC, suppliers, contractors, and collaborators.
* Identifies areas of potential risk and assists the FMC management team in developing and implementing plans to address them. Alerts management to associated liability issues.
* Designs and supports metrics to track the performance of operations and quality systems. Performs trend analysis to monitor process and facility performance.
* Provides leadership to the QA staff in the areas of personnel development; compliant documentation and record review; evaluation of Supplier Vendor Files.
* Represents the QA department on cross-functional teams, ensuring that department concerns are effectively communicated.
* Assists in development of departmental budgets. Participates in the forecasting process, and assessment of headcount requirements.
* Supervises and trains Quality Assurance Specialists. Supports the training and development of specialists across all areas of operation at FMC.
* May participate in occasional vendor audit as required - <10% travel
* High level of technical writing, risk assessments.
* Prior confirmed experience in audit management, vendor audits, knowledge and experience.
* Experience in building action plans, problem solving and decision making in a timely manner for on-budget on time objectives.
* Clear vision in establishing Supplier Quality systems within the biopharmaceutical industry.
* Some material qualification knowledge.
* Assignments are received in task-and objective-orientated terms.
* Provides direction to subordinates based on general policies and management guidelines. Work is reviewed upon completion for adequacy in meeting objectives.
* Interprets and executes policies and procedures that typically affect subordinate organizational units.
* Recommends modifications to operating policies.
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.