"With an exciting development and commercialisation program ahead, we now seek an experienced Quality Manager/Senior Quality Associate to support drug and device manufacture and commercialisation, and other internal development projects."
Quality Manager / Senior Quality Associate • Do you have experience across the full range of QC and QA disciplines working with both medical devices and pharmaceuticals? • Join our dynamic and innovative company at an exciting time as we prepare for new product commercialisation/release • 12 month full-time parental leave contract
The Company Starpharma is a leading, ASX-listed biotechnology company with a proven technology platform that is being applied in a wide range of industrial and healthcare applications for the development of innovative products.
Starpharma’s lead product, VivaGel®, is under clinical development for the treatment and prevention of a number of different genitourinary conditions and illnesses. Starpharma is collaborating with world-leading condom companies, Ansell and Okamoto, to market VivaGel®-coated condoms in key geographical regions.
With an exciting development and commercialisation program ahead, we now seek an experienced Quality Manager/Senior Quality Associate to support drug and device manufacture and commercialisation, and other internal development projects.
Starpharma offers an attractive salary package, excellent location and facilities and a great opportunity to contribute to the development and release of innovative products.
Where do you fit in?
Working closely with the development and regulatory affairs teams and other talented and committed professionals in a stimulating work environment, your key responsibilities will include: • Leading regulatory interactions with respect to quality audit and preparations for commercial release of Starpharma products • Completing QC review / release of device components and products • Quality oversight of post-market surveillance activities • Owning all vendor assurance activities, including quality agreement preparation and negotiations • Managing and conducting internal and external auditing functions • Leading the ongoing Quality Management Review process Oversight and management of the CAPA and change control systems • Guiding regulatory strategy with respect to compliance of development and manufacture activities • Overseeing validation programs • Preparing and maintaining quality systems documentation and all records management
Applications must explicitly address the following key selection criteria: 1. Applicants must have the right to live and work in Australia 2. Tertiary qualification, preferably in analytical and/or organic synthetic chemistry 3. Quality function experience in supporting product (medical device and drug) development and commercialisation – the role requires 5-10 years’ experience as a minimum 4. In-depth understanding of international GLP, GMP, and ISO quality systems and regulations 5. Experience in, and responsibility for, device and/or drug product QC review and release 6. Prior experience in managing company interactions for regulatory authority audits 7. Conduct of internal/external vendor audits 8. High quality document preparation skills, including advanced word processing skills 9. Prior experience in reviewing technical reports and regulatory submissions 10. Experience with document/records database management.
In addition to the role-specific technical skills, we seek someone with commercial acumen, the ability to work to set timelines, and strong teamwork and negotiation skills. NB: Title and level of role will be determined based on the experience and skills of the preferred candidate. Interested?
Please email your application to [email protected] or phone Jeremy Paull, VP Development & Regulatory Affairs on (03) 8532 2736 for a confidential conversation
SPL Price at posting:
$1.37 Sentiment: LT Buy Disclosure: Held
