Quality Manager

Work Schedule

Environmental Conditions

Job Description

DESCRIPTION:

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll 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 Youll 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:

• Bachelors 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.

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 100000 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!

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.