Quality Assurance Manager

**Quality Assurance Manager**

**Are you highly experienced in Quality Assurance Manager and thrive on achieving excellence in a dynamic environment? Do you deliver standout results first time, every time? If so, you'll fit right in at Mayne Pharma.**

**At Mayne Pharma, the results speak for themselves**

Mayne Pharma has a 40-year track record and has set about delivering the highest quality products and strictest quality control protocols for the pharmaceutical industry. This extends to a robust portfolio of branded and generic drugs spanning dermatology, women's health, men's health and more. We're always searching for ways to improve. That's why we develop new technologies, delivery systems and products to better serve our customers. To make this possible, Mayne Pharma employs over 450 staff globally.

**Culture comes first**

We put people first at Mayne Pharma. And the reason is simple: we know that cultivating a strong culture means we can deliver on our promise - to offer better, safer and more accessible medicines. To make hard work rewarding, you will enjoy a competitive salary, development opportunities and many health, wealth and lifestyle benefits.

**Did we mention our values?**

Accountability, agility, creativity, empowerment, integrity and passion. That's what we stand for. So if these resonate with you, you've found the perfect match.

**Here's where you come in**

The Quality Assurance Manager is a key member of the Salisbury Management Team responsible for the overall quality assurance for the site's GMP activities. The Quality Assurance Manger role is one that is both challenging yet rewarding. As a highly experienced professional you will ensure cGMP procedures are followed, supporting the compliance of existing and new Mayne Pharma products and manufacturing processes.

Using your wealth of knowledge, you will help to mentor and coach other members of the organisation, building their knowledge and confidence in regards to Quality Assurance and compliance.

You'll be supported every step of the way as part of a large, high achieving Quality Team.
- **Your responsibilities, at a glance, will include**:_
- Lead and manage the Quality Assurance (QA) function, ensuring compliance with GMP, regulatory, and company quality standards.
- Oversee the implementation and continuous improvement of the Quality Management System (QMS), including SOPs, training, CAPAs, change controls, product complaints, and risk assessments.
- Responsible for translating the company's GMP quality strategy into tactical policies, processes and procedures to meet regulatory (principally USFDA, TGA, EMEA, but also other RoW authorities), medical, health and legislative standards.
- Develops, implements, prioritises and communicates the site's GMP quality strategy and its GMP quality programs. T
- Ensures site GMP quality programs meet customer and regulatory expectations and develops and implements employee communications and training programs in connection with the site's GMP quality objectives, strategies, and processes.
- Ensure QA release of raw materials, packaging, intermediates, and finished products, including delegation to the Authorised Person for Release for Supply.
- Maintain inspection readiness and lead/support regulatory, customer, and internal audits.
- Drive quality performance through monitoring, reporting, and review of key metrics and Product Quality Reviews.
- Collaborate with Technical Operations and Manufacturing to ensure compliant processes and support New Product Introductions.
- Provide training and development to staff to build quality capability across the site.
- Identify and implement quality improvements as part of site continuous improvement initiatives.

**You need to tick these boxes**

We select applicants based on capability and aptitude. But we also emphasise cultural fit. Therefore, you'll need to have a positive mindset and be prepared to take ownership of your performance.
- To be successful in this role you will also have:_
- Tertiary qualifications in a relevant scientific discipline (Pharmaceutical Science, Chemistry, Pharmacy) or related field
- 10+ years of experience in Quality Assurance in the Pharma industry.
- Maintain a strong understanding of regulatory requirements (e.g. TGA, FDA, EMA) in the Pharma industry.
- To understand changes to quality policies, manufacturing processes, product recipes, or specifications are thoroughly assessed for regulatory and compliance impact.
- Ensure updates are implemented in alignment with GMP standards and Market Authorisation conditions.
- Experience leading internal audits and regulatory agency inspections
- Technically proficient and computer literate (MS Office), with strong communication, problem-solving, and decision-making skills. Able to clearly present complex information in both written and verbal formats.
- Highly organised, detail-oriented, and adaptable, with the ability to manage multiple priorities, work autonomousl