Quality and Compliance Lead Job at Montefiore (Sydney)

Gvp compliance lead

BioMarin is looking for an individual with experience working in Pharmacovigilan...

Location

United States

Salary:

176000.00 - 242000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Vice President, Report Conformance Testing Quality Assurance Lead Analyst

The Finance Quality Assurance, Testing, and Validation (QATV) team ensures the h...

Location

Philippines , Taguig

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

6-10+ years of relevant experience, within the financial services industry preferred
Regulatory Reporting experience preferred
Background in CCAR, Liquidity, RWA, Basel, Audit, Testing or Compliance Testing will be an advantage
Recognized technical authority for an area within the business
Requires communication and diplomacy skills in order to guide and influence others
Experience and demonstrated ability to manage competing priorities in a complex and dynamic environment
Self-motivated with the ability to make decisions in the absence of detailed instructions
Proficient Microsoft Office skills
In depth knowledge of banking products / systems preferred
CPA preferred

Job Responsibility

Contributes to the design, roll-out and governance of financial solutions
Participates in formulating and setting strategic direction for the process, organization and architecture covering Finance across Citi businesses, products, functions and locations
Assists in setting business and information architecture standards for Finance
Plays a part in settling and operating necessary forums and frameworks to establish and govern policies and starts for global Finance processes
Participates in assessing and incorporating changing business, regulatory and market information needs into finance processes and applications
Manages a small team, or function as a single incumbent with management responsibilities for a function
Integrates expertise and industry expertise within a defined area
Advises on standards around which others will operate
Coordinates and contributes to the ideas of the entire function
Performs other duties and functions as assigned

What we offer

Extensive on-the-job training and exposure to senior leaders
Traditional learning opportunities
Chance to give back and make a positive impact through volunteerism
Resources to meet unique needs
Empowerment to make healthy decisions and manage financial well-being
Opportunity to grow career, give back to community, and make a real impact

Fulltime

Food Quality Compliance Specialist

The Quality Specialist will support both business teams and suppliers in the IKE...

Location

United States , King of Prussia

Salary:

Not provided

IKEA

Expiration Date

Until further notice

Requirements

Background in food quality assurance, engineering, risk management, and production development
preferably having a food quality assurance or engineering education (2-5 years of working experience within the food industry)
Auditing experience and skills
Certification and practical knowledge of HACCP and HARPC analyses, able to identify gaps
Knowledge of Quality Management Systems and Quality tools
Are result oriented, high energy, and self-driven
Able to assess manufacturing process
Fluent in English (both written and verbal)
Comfortable with traveling up to 50-60% (air travel, domestically and internationally)
Able to drive and hold a valid driver’s license

Job Responsibility

Plan and perform food related audits and verifications and execute assessments according to IKEA standards working instructions
Support the business teams and suppliers in implementing the containment and corrective actions
Coach, inspire, and enable business teams and suppliers in the IKEA quality standards as well as in utilization of problem-solving tools in the daily work and specifically related to quality deviations to continuously maintain and improve compliance performance and create a compliance culture
Review of importers FDA Foreign Supplier Verification Program (FSVP), hazard analyses, documentation, and procedures in accordance with requirements and legislation
Lead and facilitate effective trainings for both internal and external business partners to develop competence of local, global, and IKEA-specific requirements
Update and maintain all necessary systems where reports and results are registered
Secure supplier & product quality/safety compliance following GFSI standard
Lead and participate in global/local projects related to quality
Collaborate across globe within quality matrix to develop IKEA food safety and quality policies

Fulltime

Operational Risk Management - Quality Assurance Lead - SVP

Operational Risk Assurance teams support the Global Operational Risk function by...

Location

United Kingdom , Belfast

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Substantial years of experience in Internal Audit, Operational Risk Assurance or Compliance Assurance with strong knowledge of 2nd line Testing & Monitoring routines
Outstanding communication and influencing skills through all levels of the organization and with external partners and vendors
Exceptional relationship management skills
In depth knowledge of Assurance Methodologies, technology platforms supporting 2nd line Risk Management
Ability to effectively communicate complex topics to a broad audience
Detailed oriented with analytical skills
Expert in Microsoft Office Tools
Bachelor’s/University degree, Master’s degree preferred

Job Responsibility

Responsible for maintaining and evolving the ORM Quality Assurance Methodology and desktop procedures
Establishes and oversees the execution of ORM Quality Assurance for the whole of Global ORM teams
Lead and manage a team of Quality Assurance testing team and be responsible for coaching and development of the team
Responsible for undertaking or contributing to certain governance processes such as annual planning, change management of annual plans
Responsible for providing challenge to the ORM coverage and Risk SME teams for Independent Challenge activities including and undertaking quality assurance activities for areas as advised by the Head Operational Risk Assurance from time to time
Co-ordinating and managing stakeholder engagements within wider Risk organization
Responsible for providing management information
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behaviour, conduct and business practices, and escalating, managing and reporting control issues with transparency

What we offer

Generous holiday allowance starting at 27 days plus bank holidays
increasing with tenure
A discretional annual performance related bonus
Private medical insurance packages to suit your personal circumstances
Employee Assistance Program
Pension Plan
Paid Parental Leave
Special discounts for employees, family, and friends
Access to an array of learning and development resources

Fulltime

Head of Quality, Regulation & Estates Compliance

Head of Quality, Regulation & Estates Compliance role for a reputable care organ...

Location

United Kingdom , Ashford, Kent

Salary:

65000.00 - 75000.00 GBP / Year

Office Angels

Expiration Date

Until further notice

Requirements

Extensive experience in Quality Assurance within the care sector
Ideally with background as a CQC inspector
Registered General Nurse (RGN) qualification is highly desirable
Proven track record in social care settings with extensive experience in reviewing and auditing
Solid understanding of the Social Care Act 2012, CQC Regulations, and Safeguarding protocols

Job Responsibility

Lead quality assurance activities to ensure homes meet and exceed regulatory expectations
Conduct in-depth audits and design innovative processes for continual improvement
Stay updated on CQC regulations and implement necessary changes across homes
Monitor Estates compliance, ensuring all checks and certifications are correctly filed and maintained
Collaborate with senior management and staff to foster culture of excellence
Deliver training programmes for 500+ staff members
Manage escalated complaints and grievances
Conduct quarterly audits and maintain comprehensive records

What we offer

Electric company car (valued at £7k)
Statutory pension
25 days annual leave
Access to perks through Perk Box
Supportive working environment
Opportunities for professional development and growth

Fulltime

Lead Quality Inspector

Provide guidance, direction, and coordination of work to the Quality Control sta...

Location

United States , Buffalo Grove

Salary:

Not provided

Nemera

Expiration Date

Until further notice

Requirements

Must be able to perform all quality inspector functional job responsibilities
Should have good working knowledge of raw materials, production processes, costs and other techniques to maximize the effective manufacture and distribution of product
Must be self-directed and demonstrate skills in planning and organizing
Knowledge of inspection tools, use, and maintenance of those tools required
Associates degree or minimum three (3) years related work experience with one of those years in a lead role preferred
Excellent oral and written communication skills
Ability to apply basic mathematical concepts
General knowledge of PC applications such as Microsoft Word, Excel and Database software required
Good understanding of the English language. Able to read, write and speak English
Education Level: High School Diploma

Job Responsibility

Provide guidance, direction, and coordination of work to the Quality Control staff to ensure continuous production and distribution of products consistent with established standards
Address quality issues and concerns during production and sample runs
distribute or assign work as needed
Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards
Assist Quality Control Manager in coordinating and executing objectives throughout the company in cooperation with other Lead Quality Inspectors to maximize product quality and operating system efficiency/effectiveness to minimize costs
Direct and coordinate the activities of Quality Inspectors engaged in the evaluation of goods
Perform all the functional duties and responsibilities of the Quality Inspector
Plan and establish work schedules, assignments, and production sequences to meet production goals
Read and analyze charts, work orders and other records and reports, in order to determine resource requirements
Review data and documentation for accuracy and correctness and ensure processing is performed within established time expectations

Fulltime

Quality and Compliance Lead

Montefiore

Location:
Australia , Sydney

Category:
Nursing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 27, 2026

Expiration:
April 23, 2026

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Quality and Compliance Lead

Montefiore

Location:Australia , Sydney

Category:Nursing

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 27, 2026

Expiration:April 23, 2026

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Location:
Australia , Sydney

Category:
Nursing

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Job Posted:
March 27, 2026

Expiration:
April 23, 2026