Work Schedule
Standard (Mon-Fri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
DESCRIPTION:
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
How will you make an impact?
This is a leadership role within the ANZ BCD Quality team. The Quality manager leads day-to-day quality operations at the Auckland site and takes accountability for achieving quality objectives while ensuring compliance with industry standards. Working with cross-functional teams, you'll provide quality oversight to manufacturing operations and quality systems. You will guide quality initiatives and cultivate a positive culture of quality excellence. This role allows you to play a role in strategic leadership and offers the opportunity to make a meaningful impact by meeting and exceeding customer expectations, protecting patient safety and supporting innovative research.
Location/Division Specific Information:
This role is located at Penrose, Auckland manufacturing site, which forms part of the Biochemicals Division.
About the Role
What You'll Do:
Oversee the performance of the Quality Management System (ISO 9001, cGMP and MPI requirements) at the Auckland and Nelson manufacturing sites.
Lead and manage Quality Assurance and Manufacturing Quality teams at the Auckland Penrose site.
Lead, coach, and empower team members to engage in cross functional projects, continual improvement and development.
Review, analyze, and translate quality system requirements into actionable deliverables.
Lead regulatory and customer audits for the Auckland site and respond to customer complaints or queries, demonstrating a high level of customer responsiveness.
Conduct periodic QMS assessments for regulatory compliance and recommend improvement strategies.
Review manufacturing processes, validation plans and reports for regulatory alignment.
Communicate quality and compliance matters effectively across departments.
Make necessary process and training adjustments for sustained compliance and high standards.
Responsible for the co-ordination, approval and maintenance of all ANZ BCD Thermo Fisher Scientific Quality documentation and records.
Responsible for batch review and release for supply for all ANZ BCD finished products.
Lead quality assurance and manufacturing quality functions including but not limited to: deviation management, CAPA, root cause analysis, change management, internal audits, customer complaints for Auckland and Nelson sites, quality Gemba.
Support technical and customer facing teams by providing subject matter expertise for quality issues with regards to the ANZ Gibco product range and processes.
Take active part in BCD initiatives by building links with affiliate BCD sites.
Demonstrate strong critical thinking in complex quality scenarios
Adhere to 4-I values: Integrity, Intensity, Innovation, and Involvement.
Be the designate responsible for ANZ BCD quality in the absence of Head of Quality ANZ.
Perform other duties as assigned.
Working hours are typically 8.30am – 5.00pm Monday to Friday.
REQUIREMENTS:
Keys to Success:
Education:
Bachelor's degree (or higher) in a science, engineering or related field.
Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy or related.
Additional certifications (ASQ, Six Sigma, etc.) desirable.
Lead Auditor certification in ISO 13485 / ISO 9001 preferred.
Experience:
Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP) and proven ability to implement, improve or maintain such systems.
Minimum of 8 years of professional experience in a Quality, Technical or Operations related role.
Minimum of 3 years' experience as people manager
Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis).
Proficiency with quality management system software such as TrackWise, electronic Document management systems, ERP, Learning management systems.
Experience leading internal/external audits and regulatory inspections.
Experience with continuous improvement methodologies (Lean, Six Sigma, other).
Project management experience preferred.
Demonstrated ability to develop, mentor and empower teams
Knowledge, Skills, Abilities:
Experience at effectively communicating complaints, risks, Corrective and Preventive Action (CAPA) and improvements
Strategic mindset and goal orientation.
Ability to persuade, negotiate, gain commitment from stakeholders and resolve issues.
Demonstrated ability to lead in a fast-paced technical environment.
Ownership of actions and effective project/people management.
Strong relationship-building and conflict resolution abilities.
Experience managing conflicting demands.
Ability to analyze and process data and draw the appropriate conclusions.
Focus on customer needs and ability to manage customer/supplier relationships.
Ability to promote quality culture across all levels of the organization
Skill in cross-functional collaboration and stakeholder management
Strong analytical and problem-solving capabilities
Clear written and verbal communication skills
Benefits:
Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.
Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits including company paid private health insurance and risk benefits insurance (via selected company provider), wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
Flexibility: Balance your work and personal life with flexible arrangements.
Extra Leave: Benefit from generous leave policies, including birthday leave, and company paid parental leave.
Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.