Senior Quality Control Manager

Who we are

PolyNovo is a disruptive medical technology company, headquartered in Melbourne. We design, develop, and manufacture innovative dermal regeneration solutions, using our patented bioabsorbable polymer technology NovoSorb®. Our lifesaving products have revolutionised the treatment of burns, major trauma as well as multiple emerging indications, and impacted the lives of over 70,000 patients globally.

With a footprint in 46 countries and 300+ staff across a range of locations, PolyNovo continues to grow, and opportunity awaits.

Learn more about PolyNovo by visiting our Website or our LinkedIn page.

About The Role

PolyNovo is currently searching for a Senior Quality Control Manager to join the Quality team. Reporting to the VP Quality, the Senior Quality Control Manager will be responsible for leading all Quality Control activities, ensuring products are manufactured in accordance with ISO13485, GMP, and applicable regulatory requirements.
This role provides technical leadership, manages QC personnel, and drives both compliance and continuous improvement efforts.
As a key member of the Quality Leadership team, the position also plays a critical role in partnering with QA, Manufacturing, PMS, Validation, R&D, and Regulatory to maintain consistent product quality and safeguard patient safety.

Key Responsibilities

QC Leadership

• Lead and manage the QC team across incoming, in-process, and final product inspection and testing.
• Maintain and update QC procedures, documentation, sampling plans and test methods.
• Ensure all QC activities align with ISO13485, GMP, company and relevant regulatory authority requirements.

Laboratory & Testing Oversight

• Lead development and implementation of GMP methods and procedures for inspecting, testing, and evaluating the identity, purity, and safety of raw materials, intermediates, and finished products, ensuring their conformity to approved specifications and regulatory requirements
• Develop, update, and validate, Standard Operating Procedures (SOP), stability protocols, qualification protocols, test methods, and other documents to support GMP QC operations. Ensure the currency and applicability of the standards and guidelines used for all analytical methods.
• Oversee QC laboratory operations, including test method validation, equipment validation, and environmental monitoring requirements.
• Ensure appropriate data integrity principle are understood, implemented and confirmed by all QC team members. Ensure traceability is embedded and routinely confirmed.
• Review and approve QC test results and relevant product release documentation.

Non-conformance and Issue Management

• Manage the investigation of non-conformances and out of specification occurrences.
• Coordinate root cause analysis activities when required and facilitate escalations when appropriate.
• Support and drive the implementation of CAPA and verification of effectiveness when required.

Cross-Functional Collaboration

• Work closely with QA, Manufacturing, Engineering, Validation, R&D, Regulatory Affairs and Supply Chain to resolve quality issues as they arise and support production continuity.
• Provide QC input to design transfer, validation activities, and change control processes.

Quality Systems and Continuous Improvement (CI)

• Continuously optimise and improve QC procedures, including sampling procedures.
• Use QC data, trend analysis and visual performance management to identify quality risks and improvement opportunities
• Support internal and external audits as the QC subject matter expert. Develop QC teams members to also provide this type of support.
• Drive initiatives that enhance efficiency, consistency, and compliance within the QC team.

People leadership:

• Lead, mentor, and develop QC staff to maintain a high level of technical competency and compliance within the team.
• Allocate resources to meet production and project priorities.
• Align and inspire team members by communicating a clear vision for success.
• Envision a better future and champion change. Bring people along and align actions with corporate strategy.
• Foster a culture that lives into the PolyNovo values. Lead with integrity, fairness, ethics, and compliance.
• Assess, attract, hire, develop and engage the best diverse talent to meet current and future needs of the business.
• Understand and effectively use Performance Management and Development processes and tools to drive engagement, performance and continuous development within the team
• Provide feedback and coaching that is invested in developing people, improving outcomes, and managing relationships effectively.
• Establish and communicate clear goals and roles, commitment, inclusion, and collaboration.

Qualifications:

• Tertiary qualifications in Science (preferably Chemistry) or related discipline; Plus 
• A minimum of five (5) years of relevant Quality Control experience in medical device or pharmaceutical manufacturing. A background in Microbiology an advantage.

Experience:

• Experience in materials properties and polymer characterisation equipment an advantage
• Experience in and knowledge of manufacture of medical devices in a GMP environment, including audits.
• Strong understanding of regulatory guidelines relevant to the role.
• Minimum 2 years supervisory experience required.
• Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Ability to analyse complex data to identify sources of variability or error and define corrective actions.
• Excellent attention to detail.
• Ability to interact constructively with staff in other departments.
• Independence with efficient time management and organizational skills.
• Excellent written and verbal communication skills.

Why PolyNovo?

Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry.

• Multinational, ASX 200 listed and values-led business dedicated to redefining healing for the benefit of our patients
• Unique platform technology, an exciting pipeline of highly innovative products
• Diverse, inclusive and flexible workplace culture
• Career development opportunities and unlimited access to online learning
• Rewards platform with access to discounts at over 450+ Australian retailers
• Paid parental leave for primary and secondary carers, Nurture Days, and more
• Salary packaging including novated car leasing.

Apply Today

Please send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted.

We like AI for lots of things… just not résumé review. Your application is read by actual human beings. No automated screening tools are used in our hiring decisions.

Please note only applicants with full working rights in Australia will be considered.

PolyNovo is committed to creating a workplace that values equity, diversity, and inclusion. We recognise and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed.

Learn more about PolyNovo at: https://au.polynovo.com/company/