Site Quality Head

Site Quality Head

About Us:

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

The Role:

The Site Quality Head is a key Leadership role, primarily tasked with maintaining compliance with the code of Good Manufacturing Practice for Medicinal Products and the site Licence to Manufacture under the Therapeutic Goods Act 1989.

Our Team:

The Quality team are an essential part of the Manufacturing and Supply team, who ensure continuation of our licence to operate whilst maintaining good practices.

Main responsibilities:

• Working in a Matrix structure to align closely with local, Regional and Global objectives
• Using your Leadership skills to both maintain and continually improve on business quality standards, this function will drive the philosophy of "Efficient Compliance" utilizing a risk-based approach
• Using the philosophy of Efficient Compliance the role is responsible for identifying and implementing opportunities to improve site Quality performance, in areas such as Customer complaints, deviations, Right First time, CAPA closure, human error reduction
• Coordinate quality operations in relation to New and Existing Product Development (NPD/EPD) whilst balancing key resources to support

Quality Compliance:

• Plan, direct and coordinate Site Quality operations including Quality Control and Quality Assurance
• Quality related activities on site, including QC, QA, product release, validation, stability and site regulatory issues
• Oversees that GMP standards and group directives are met on site and takes responsibility as the signatory on the TGA licence
• Acts a main liaison during TGA Audit process
• Ensure compliance to latest Pharmaceutical Inspection Co-operation Scheme (PIC/S) code
• Ensures completion of customer / corporate and regulatory inspections
• Implements strategies to improve Site Quality compliance
• Management of Customer Complaints and associated reporting
• Development of a yearly Site Quality plan

Site Quality Management:

• Ensures departmental budgets are set and achieved
•  Adheres to Monthly KPI reporting and communication on quality performance
• Oversees performance and KPI adherence of all Quality teams and actively looks for and implements improvements in productivity and efficiency
• Facilitation of efficient Risk Assessment & Root Cause Analysis in Non-Conformances
• Supports new launches through direct involvement or delegation via team
• Support plant delivery & plant cycle time performance
• Reports in a timely manner any quality failures / near misses or potential issues to the Site Director and GMQO Site Support
• Acts as recall co-ordinator in times of product recall and liaises with authorities over Quality matters

Validation:

• Completes annual validation program
• Completes cleaning, process and equipment validation activities
•  In conjunction with IS, ensure compliance of Computer systems validation

Supplier Quality Management:

• Coordinates and conducts internal, supplier and contractor audits to the requirements of cGMP, cGLP cGWP
•  Ensures Vendor Assurance system maintained
•  Supports purchasing, sourcing and price reduction objectives for material supplier approvals
• Completes, implements and ensures currency of Quality Agreements for subcontractors and looks for opportunities to improve

Quality Control:

•  Develops a World Class Laboratory through effective leadership and appropriate investment
• Develops a QC Laboratory team that can support the company direction and meet customers' needs
• Manages and Contributes to improving cost performance and efficiencies in Quality Control
• Controls the implementation of new methods in order to minimise business disruption

Relationships & Influence:

• Key member of IA Site Leadership Team (SLT) and is therefore expected to contribute to programs such as ‘Go Gemba’, Town Halls, AMEA Connectors etc
•  Member of CHC Extended Leadership Team (CHC XLT) and is therefore expected to contribute and represent IA interests in Bi-Annual XLT meetings
• Participates within relevant industry associations and TGA forums to network and influence the decisions of the TGA.
•  Is involved in continued learning through participation in associations, conferences, Industry meetings and involvement within the corporate quality network.
• Creates, approves, implements and assigns appropriate control

About you

• Experience in developing and maintaining Quality Management Systems
• Must have been involved in leading TGA Audits in relation to Therapeutic Goods Act 1989
• Experience with Pharmaceutical Inspection Cooperation Scheme (PIC/S) code
• Background in leading multi-skilled Quality professionals across QA and QC

Soft skills:

• Ability to synchronise and collaborate across multiple regions, cultures and timezones
• Forward thinking mindset and strategic risk-taker
• Prioritise and manage deadlines and KPI Driven in nature
• Sophisticated in dealing with senior stakeholders, high level communication and presentation skills

Technical skills:

• Computer literacy and Business reporting: Creates, approves, implements and assigns appropriate control of all Quality Documentation

Education:

• Bachelor’s Degree in Chemistry or Science
• Qualifications in Business, Pharmacology/Pharmacy and complimentary medicines also highly regarded

Languages: High level written and spoken English

Work Rights: You must have full Australian work rights 

Pursue progress, discover extraordinary!

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!