Manager, Global Clinical Quality Account
PCI Pharma ServicesAbout the role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Plans, directs, and coordinates Quality activities of a designated Clinical Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Select, supervise, empower, coach, develop and retain a team of qualified individuals including: Quality Specialist(s) and Quality Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality product on time. Drives project success through active leadership to provide PCI a competitive advantage in long-term quality customer management for key strategic accounts.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Coordinate with Global Program Managers to establish a Global Relationship Management Team (RMT) ensuring strong support both internally and externally.
- Participate in weekly RMT meetings, continually evaluate team capacity and structure to support Client provided forecast and timelines as it relates to Quality across global PCI sites.
- Maintain awareness of all projects, contacts, programs and operational/client issues, escalation, and concerns.
- Develop standardized Quality expectations, metrics, and ways of working to ensure harmonization across sites and achievement of established timelines.
- Lead Quality efforts in the associated periodic (weekly/monthly/quarterly) client reviews.
- Maintain understanding of key aspects within Technical/Quality Agreements and appropriate Supply Chain documents.
- Ensure the appropriate team structure is in place by performing routine workload analysis to manage headcount and to ensure we deliver on customer and business commitments.
- Ensure strong alignment and c
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