Director, Quality Unit - QA/QC
Location:
Philadelphia , Pennsylvania
Posted:
October 18, 2017
Reference:
R-014705
Director, Quality Unit (QA/QC) - Red Lion, PA
MedImmune is the global biologics research and development arm of AstraZeneca. We work as partners in bringing life changing medicines to patients, sharing and benefiting from each other's strengths.
Director, Quality Unit (QA/QC) in Red Lion, PA directs Astra Zeneca's Quality Unit (QA/QC) in PA. The Director ensures Quality Assurance and Quality Control activities (internally and externally) are performed per Astra Zeneca's Quality Standards and applicable requirements. Provide leadership, direction and mentoring to ensure the Quality Unit successfully meet site objectives in support of Corporate Goals and operates within the regulatory environment.
Main Duties and Responsibilities
  • Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organization, to assure a functionally independent quality unit
  • Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency
  • Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual improvement
  • Ensures that the organization complies with the relevant cGMP's and standards concerning the manufacturing and control of drug product
  • Participates fully in inspections and audits, and ensures that corrective action plans are agreed, implemented, monitored and completed to maintain compliance
  • This is a critical leadership position of a significant Quality function with high expectations for effective leadership and the learning and development of the supporting staff and organization.
  • Ensures that all site related Quality disposition activities are conducted in compliance with corporate standards and applicable regulations
  • Defines the values, culture, and goals for the site Quality Unit
  • Responsible for all aspects of Quality at the Pennsylvania Manufacturing Facilities
  • Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
  • Ensure and monitor compliance by team members and third parties by (a} positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, {b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of noncompliance.
  • Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
  • Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.
Essential Requirements
  • Bachelors or Master's Degree in Sciences, Engineering or related field
  • Minimum 10 year's management experience in (bio) pharmaceutical industry with at least 5 years in QA/QC
  • At least 5 years of experience with Health Inspections i.e. (FDA, EMEA, MHRA, ANVISA, HC, KFDA) Previous experience in hosting and leading regulatory inspections (domestic & international) and internal audits is required
  • Proven track record in managing diverse fast paced organizations
  • Aseptic manufacturing experience
  • Strong international regulatory and compliance experience with organizations such as the FDA, MHRA, EMA, ANVISA, HC and KFDA
Desirable Requirements
  • It would be desirable for the candidate to have held a similar position in (or have similar supervisory experience) supplemented with experience from manufacturing, technical support or Research & Development.
  • Strong experience in packaging and multi-product quality compliance is highly desired.
  • Successful prior experience in managing or direction Quality Assurance and Quality Control Functions in commercial biotech preferred
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.
~ bsp

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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