Quality Assurance Manager

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. Purpose: The Quality Assurance Manager is accountable for the management of the cGMP Compliance and relevant Regulatory Licensing requirements for the PCI Melbourne Site. This position is responsible for hosting regulatory inspections and responding to inspection reports. This position will oversee, maintain and drive improvements in the Pharmaceutical Quality Management System, including GMP software, to ensure compliance to regulatory and procedural requirements. This role will also be significantly involved in Quality Investigations and Root Cause Analysis, responsible for Supplier Management, Deviations, CAPA, Complaints, Audits (i.e. internal, external and regulatory), PQS monitoring/reporting and Quality Improvement Initiatives. General description of this position’s role in the Department: The Quality Assurance Manager will interact with client and other external parties, Regulatory Bodies, Boards of Health (e.g. TGA, DHHS) to manage compliance activities and maintain current licensing conditions. This position is responsible for responding to inspections and ensuring timely closeout of agreed remediation (inspection response). This role will maintain and report quality metrics and host Quality Management Review forums and other meetings to progress quality performance. Primary responsibilities & tasks of this position are: Oversee the implementation and compliance of the Pharmaceutical Quality System at PCI Melbourne, including the ePQS. This includes (but is not limited to) Deviation Management, Customer Complaints, CAPA, Training, Change Control, Supplier Management, Validation and improvements to other GMP software systems as required Oversee and approve PQS improvements, including procedures and processes for the evaluation, assessment and disposition of suppliers, deviations, change controls, complaints and CAPA Oversee and conduct site/virtual/desktop supplier audits (e.g. new, periodic and for cause) Approve supplier and client Quality Technical Agreements Oversee the internal audit programme and schedule adherence Oversee inspection and audit preparedness including training, responses and reviews Host and participate in client and regulatory inspections and the responses as required Support the completion of other compliance team responsibilities as required (e.g., CAPA completion, Deviation investigations and Customer Complaint investigations, Client Audits, Internal audits, Regulatory Inspections, MasterControl support etc) Oversee training related to PQS functions as required Maintain regulatory licences, and complete applications timely to ensure licence currency Lead, support and oversee quality investigations related to deviations and customer complaints using root cause analysis tools to ensure appropriate investigation, determine resolution and disposition Lead, support and oversee corrective and preventative action completion and effectiveness reviews Manage and support the completion of Quality Monitoring Reviews, and where appropriate other quality performance metrics, for trends and opportunities for continual improvements of products, processes and the PQS. Manage and drive continuous improvements to assist in enhancements in departmental operational performance, compliance to regulatory requirements, improvements in site Standard Operating Procedures (SOPs) and meeting external and internal customer requirements, with respect to quality, service, and lead time. Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies. Ensure timely and effective communication and escalation processes to raise quality issues to Senior Management and Quality Director. Provide business continuity by performing responsibilities related to Quality Director, and other Quality Managers (as required) Other duties as advised by the Quality Director Mandatory qualifications & experience: Bachelor of Science, Pharmacy or related Discipline. Minimum +10 years experience in cGMP pharmaceutical manufacturing facility, ideally in a Quality Assurance, Quality Control or manufacturing position. Excellent written and verbal skills with good attention to detail Desired qualifications & experience: Two years experience in a managerial or supervisory role Pharmacy or relevant science degree with manufacturing experience. Experience in customer and regulatory authority audits. Auditing and/or hosting audits Behavioural competencies required for this position: High level of professionalism, ethics, quality of work, communication and responsiveness at all times Communication and responsiveness always Positive, 'can-do' attitude, embraces and 'lives' PCI's Vision and Values Analytical thinker and solution finder/problem solver Collaborative, team player Objective and robust decision maker Excellent interpersonal, written, and verbal communication Self-motivated and achievement orientated Trusting and trustworthy Conscientious and diligent Positive embraces and responsive to change Working relationships: The position will report to the Quality Director and will work closely with other Quality Managers and site Management. In addition to this, the Quality Assurance Manager will work closely internal and external stakeholders including (but not limited to): Project Management, Finance, Production, Warehouse, Human Resources, Engineering/maintenance and regulatory bodies (as required). Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: 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, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion 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. #J-18808-Ljbffr