Quality Assurance Manager

**About BioCina**

BioCina is a biologics contract development and manufacturing organization (CDMO) specializing in process development and cGMP manufacture of microbial-based therapeutics and plasmid DNA, from preclinical to commercial production. The site, approved by the FDA for commercial manufacturing in 2020, has 35+ years of microbial fermentation experience and over the past 15 years, has worked on over 50 different products and has partnered with more than 30 customers globally.

We are seeking for a passionate **Quality Assurance Manager** to play a pivotal role in taking our high performing and dedicate QA team to the next level of cutting-edge quality standards and processes and drive continuous improvement.

If you are a driven and strategic leader with a strong focus on excellence, this is the perfect opportunity for you to make a lasting impact in our growing organisation.

**About the role’s responsibilities**
- Manage quality systems for documentation, investigation, complaint, vendor qualification and CAPAs across all functions within BioCina in alignment with industry standards and GMP expectations.
- Provide guidance and support for all quality related matters across the site.
- Responsible for batch review and batch release processes.
- Foster a culture of compliance and continuous improvement amongst all personnel who operate within the Quality System. Ensure that quality systems and decisions follow the regulatory requirements and foster a culture of risk-based thinking and compliance.
- Acts as an internal auditor for GMP activities conformance with established procedures and requirements of the cGMPs. Acts as a supplier auditor.
- Direct supervision of the QA department and act as delegate to Head of Quality when required.
- Lead quality on the floor and support in maintain an elite regulatory record of inspection-ready quality and compliance at all times.

**Requirements**:

- Bachelor’s or master’s in a scientific or engineering discipline.
- 7 - 10 years of working knowledge and practical experience with quality principles across manufacturing, testing, and auditing environments.
- Strong knowledge of cGMP including ICH Q7 and international codes of GMP (FDA and EU).
- Knowledge and experience in OGTR regulations.
- Experience in phase appropriate manufacturing requirements.
- Expert knowledge of quality systems and expectations.
- Exceptional attention to detail regarding documentation.
- Excellent communication skills and ability to work as part of a highly skilled Quality team.
- Experience using the Microsoft Office suite, in particular MS-Word and MS-Excel.
- Experience working in a biologics CDMO environment is essential.
- Experience in managing and coordinating teams, developing schedules and managing multiple simultaneous programs.

**Why work with BioCina?**
- Competitive remuneration and benefits: We offer a competitive salary, comprehensive benefits package, and recognition for exceptional performance.
- Career growth opportunities: We believe in growing our people and provide ample opportunities for career development and advancement.
- Innovation and impact: Be part of a company that goes beyond the boundaries of science and making a positive impact on patients’ lives.
- State-of-the-art facility: Utilise cutting-edge technology and work in a modern, well-equipped facility that fosters creatively and productivity.
- Collaborative environment: Work alongside with passionate and expert professionals who are dedicated to excellence and shared a common goal.

Join our team and help shape the future of biopharmaceuticals. Together, we can make a difference.

To apply, please submit your resume and a cover letter outlining your qualifications, relevant experience and why you are the right fit for this role to

**Salary**: $73,228.61 - $154,591.62 per year

**Benefits**:

- Maternity leave
- Parental leave
- Professional development assistance

Schedule:

- Day shift

Supplemental pay types:

- Annual bonus

Application Question(s):

- Are you willing to perform a pre-employment medical assessment?
- Have you worked in a CDMO Biologics environment before?

**Education**:

- Bachelor Degree (required)

**Experience**:

- Biotechnology: 7 years (required)

Work Authorisation:

- Australia (required)

Work Location: In person