We are seeking a Quality Systems Manager to join our team in Westport. The Quality Systems Manager is responsible for the processing of all electronic documentation and printing of controlled documents for Batch Records at the Westport site. The DCC and Quality Batch Issuance Department must maintain compliance with local, regulatory, and legislative requirements regarding Safety, Housekeeping, GMP, and support and comply with internal environmental health and safety policies. The role involves interaction with QA, EHS, Compliance, and regulatory affairs to ensure all internal procedures reflect current standards.
Responsibilities include:
* Manage the Document Control and Quality Batch Issuance Teams
* Oversee SOP, Manufacturing, and QA documents onsite
* Host Team Tier Board meetings
* Prioritize scheduling activities
* Collect metrics for the DCC and Quality Batch Issuance Departments
* Process team GTW records
* Oversee addition of SOPs to LMS Compliance Wire
* Approve DCC-related SOPs and internal documentation
* Coordinate onsite file retention activities
* Represent the site for Global Documentation Projects
* Coordinate global documentation updates affecting local procedures
* Serve as COE SME for Documentation at the Westport Site
Required skills and qualifications include:
* 3+ years of experience in a similar Quality Management role
* Proven leadership and team management skills
* A relevant tertiary qualification is desirable
* Strong decision-making skills and ability to work independently
* Excellent team-building skills
* Experience coordinating meetings with global and local teams
* Proficient in quality management systems
* Outstanding communication and interpersonal skills
* Excellent IT skills
Additional information includes:
* The successful candidate will have a strong understanding of quality management principles and practices
* They will be able to communicate effectively with stakeholders at all levels
* They will be proactive and self-motivated, with a positive attitude towards continuous improvement
* They will have excellent problem-solving skills and be able to prioritize tasks effectively
This position offers a competitive salary and benefits package, including opportunities for professional development and growth. We welcome applicants from diverse backgrounds and are committed to creating an inclusive and supportive work environment.
Please note: All applications should be submitted via the 'Apply now' button. Bank or payment details should not be provided when applying.