Quality Director

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 Director is responsible for overseeing and managing all quality and regulatory/licencing functions for the PCI Pharma Services (PCI) Melbourne site. This includes appropriate resourcing, and day to day operations, required for compliance to Good Manufacturing Practice, Controlled Substances (Poisons) and the importation/exportation of investigational products.

This position is responsible for the performance of the Quality Department, and is the Quality/Regulatory lead pertaining to the delivery of the PCI Site and Global strategic goals and objectives to achieve commercial success and overall compliance. This role is a conduit between site Quality and Global PCI Quality, facilitating communication, collaboration and issue resolution on global issues and projects with other PCI Global Leaders.

The Primary Responsibilities & Tasks Of This Position Are

• Ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives
• Ensure there are adequate resources and that roles, responsibilities, and authorities are defined, communicated and implemented for the Quality department
• 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, Document Management (including retention of records and data integrity), Internal Audits, Risk Management and improvements to other GMP software systems as required
• Oversee and approve PQS improvements, including (but not limited to) procedures and processes for the evaluation, assessment and disposition of suppliers, deviations, change controls, complaints and CAPA
• Oversee and approve the Periodic Quality Management Review, and oversee monitoring of the ePQS to ensure site and global metrics are met and/or exceeded
• Develop and communicate the Quality key performance indicators and promote the Quality objectives for site awareness and action as appropriate
• Oversee and approve/reject quality investigations related to deviations, customer complaints and nonconformances using root cause analysis tools to ensure appropriate investigation, determination of resolution and disposition
• Ensure validation/qualifications are completed in a timely manner and that appropriate systems are in place for the evaluation of equipment and their maintenance
• Oversee systems and approve quality contracts for clients and suppliers
• Oversee the management of regulatory licences, to ensure licences are appropriate and current
• Oversee inspection and audit preparedness including training, reviews and licence compliance adherence
• Host and participate in regulatory inspections and client audits and in the preparation of the response as required
• Engage with clients/sponsors and address client/sponsor queries (and client representatives) to enable product information transfers and compliance to clinical trial protocols and regulatory requirements
• Oversee the management of the Authorised Persons programme to ensure compliance and effective 'Release for Supply' of product
• Oversee the management, and the review and approvals of, materials and products, and perform disposition of materials and products. This may include (but is not limited to) incoming goods, manufactured materials/products and returns of materials/products
• Oversee systems to ensure all necessary testing is carried out, and supporting documents are approved (including but not limited to: specifications, sampling instructions, methods, and quality/operational procedures)
• Oversee systems to ensure stability testing and/or the assessment of results (in line with ICH requirements) are completed to support shelf life extensions and expiry dates
• Escalate critical issues and raise 'Quality Bulletins' as appropriate for local and/or global awareness to promote the review and timely correction / CAPA at the affected site, and/or other PCI sites
• Oversee recall activity and act as a representative for client recall activity, including mock recall compliance.
• Manage and approve the Quality Department budget (as defined) to ensure costs are controlled and planned in line with site financials and budget
• 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.
• Provide direction and expertise to employees to ensure the development and implementation of departmental SOPs that are compliant to regulatory requirements and are 'fit for purpose' operationally and commercially.
• Participate in the PCI Centres of Excellence as appropriate with the goal of harmonising quality systems across all PCI sites as part of the company's One PCI policy.
• 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 the VP of Clinical Quality and the Site Leadership Team
• Other duties as advised by the VP of Clinical Quality

The Mandatory Qualifications & Experience

• Bachelor of Science, Pharmacy or related Discipline
• 10+ yrs experience in cGMP pharmaceutical manufacturing facility, in a Quality Assurance or Quality Control leadership role.
• Excellent written and verbal skills with good attention to detail
• Documented cGMP training
• Exceptional verbal and written communication skills
• Proven coaching and influencing skills at all levels
• Resourceful, Role Model, Courage to Challenge, Results Driven, Approachable and Innovator
• Previous experience/working knowledge of contract manufacturing (preferred)

Working Relationships

The position will report to the VP Global Quality, Clinical Services and will work closely with the VP of the Asia Pacific Region and Senior Leadership Team at PCI Melbourne. In addition to this, the Quality Director will work closely with local and global, 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, affectional 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.