Quality Account Manager

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. General Purpose of Role:

• Plans, directs, and coordinates Quality activities of a designated Clinical Customer Focused Team to ensure that goals and objectives of the team are accomplished to standard, within prescribed time frames and in budget.
• Working across departments and European PCI Clinical sites, partner and coordinate a team of qualified individuals including: QC Specialist(s), QA Officers/Specialists and QPs while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality product, on time for the customer.
• Drives project success through active Quality leadership to provide PCI a competitive advantage in long-term quality focussed customer management.
Main Responsibilities:
• Ensuring that receiving reports, batch records and QP release request tasks are completed on time and documents shared to customer (as applicable) with tracking of on time tasks monitored/trended.
• Receive customer related information and process through applicable workstreams once data verified identifying any issues during customer receipt, batch record review or QP release to ensure appropriate resolution and tracking/trending.
• Assist with the investigation of Customer related Quality investigations /deviations /issues and the drafting of investigation reports associated with such issues on time to the Customer.
• Disposition of Events and Non Conformances (as applicable)
• Customer specific action items from audits, investigations (e.g. CAPAs) are completed on time.
• At the specified frequency, report and track/trend customer metrics/key performance indicators (KPIs)
• Regularly present for Quality on customer calls or Business Review Meetings (BRMs), being present for face to face discussions when required on-site in the region or at another facility in PCIs network or customer location.
• Assist as company liaison with customers concerning quality documentation.
• Help identify, communicate, track and resolve issues with other PCI sites (Europe and Rest of World), departments and customers.
• Attend conference calls and customer meetings; providing subject matter expert input to investigation/complaint and other quality related information.
• Assist with generating and presenting quality related metrics and key performance indicators for team's performance internally and externally.
• Assist with addressing and documenting quality events with Production, Project Management and Quality teams.
• Assist with training, developing, and mentoring QA Team members and other departmental personnel.
• Knowledge of and adherence to all relevant PCI procedures and GMP rules and guidelines.
• Develop, update, and implement procedural changes throughout Quality Management Systems across sites.
• Standardise documentation to ensure PCI's Standard for Quality is achieved throughout our customer base.
• Compile, update and analyse customer / internal data and metrics to identify potential trends and areas for opportunities.
• Utilise the Microsoft Office Suite (or equivalent) in detail to present data / facts in a professional fashion.
• Maintain positive external and internal customer relationships (at Regional and rest of world level across PCI sites/departments) with face-to-face, email and voice communication. Provide the appropriate feedback within 1 working day of notification.
• Assist with Supplier Investigations as needed.
• Assess and provide detailed reports / summaries on the impact of process changes to PCI management.
• Support PCI sites with effective, timely and accurate notification of changes to clients and other PCI sites.
• Performs other duties/quality projects as assigned by Manager/Supervisor.
Outcomes of Role:
• Partnering effectively with European PCI Clinical sites and team members across both Quality and Operations/Project Management teams to ensure Quality tasks associated with Customer accounts are completed to the desired Quality standard and on time.
• Investigations are completed on time to customers and to the desired quality standard.
• Customer activities as they relate to quality tasks are completed on time with issues trended for evaluation by site leadership or continuous improvement teams.
• Metrics or KPIs are presented to customers on-time.
• Partners effectively with customer quality/personnel to build relationships to assist in business retention/pristine customer service.
  
  Ideally a University degree in a scientific or health based field. Other qualifications would be considered if industry experience or competence can be proven.
Specific Knowledge / Skills Competence:
• Experienced in pharmaceutical industry (or related field) with good knowledge of European GMP/GDP legislation and guidelines (or ISO quality management system standards).
• Experience in performing and completing quality related investigations (deviations) with knowledge of tools to assess situations to identify root causes and effective assignment of CAPAs.
• Ideally, experience of clinical trial supplies production/distribution.
• Ideally, experience of project management principles and tools
• Proficiency with MS Office Suite programs.
• Ideally experience in hosting or participating in audits.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (https://pci.com/)

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled