Quality Assurance Operations Manager Job at Beacon Hill (Hartwell)

Manager, Quality Assurance Operations

Reporting to the Director, Quality Assurance Operations, the Manager, Quality As...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree required, preferably in biomedical sciences, regulatory affairs, clinical research, nursing, or related health sciences
Cell and gene therapy experience required
autologous cell therapy experience strongly preferred
Minimum of 5+ years of relevant experience in Quality Assurance, Quality Operations, Quality Compliance and GMP manufacturing
Minimum of 3 years providing Quality oversight of CDMOs within a GMP manufacturing environment or global pharmaceutical setting
Extensive knowledge of GMP, GCP, ICH guidelines, and FDA biologics regulations
Knowledge of federal research regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, 312, 812
45 CFR 46
ICH GxP guidance
and relevant EU/UK regulations

Job Responsibility

Provide Quality oversight of external partners across the supply chain—including CDMOs and cryopreservation sites—serving as the primary QA point of contact
Lead batch disposition activities to ensure timely, compliant, and right first time product release
Review and approve master batch records, QC test methods, validation protocols/reports, specifications, and associated documentation
Author, review, and revise SOPs and controlled documents as needed
Initiate, review, and approve investigations, root cause analyses, risk assessments, change controls, and CAPAs
Participate as a cross functional team member in process validation, analytical validation, technology transfer, and manufacturing readiness activities
Collaborate with CMC and GxP functional groups to provide QA guidance and support across development and manufacturing operations
Support internal and external audit programs, training initiatives, and inspection readiness activities
Develop, track, and report Quality metrics and KPIs for both internal processes and external partners to drive continuous improvement and ensure accountability
Work independently while fostering strong, collaborative relationships across internal teams and external partners

What we offer

health and retirement, PTO, and stock option plans

Senior Manager, Quality Assurance & Operations Excellence

The Senior Manager, Performance Improvement & Development (SMPID), Residential O...

Location

Singapore , Singapore

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Advanced in MS PPT including dynamic elements, such as videos, visually represented data, and interactive modules
Advanced in MS Excel including PivotTables, VLOOKUP, INDEX/MATCH and Data Tables
Skills in facilitating improvement strategies, managing quality improvement teams and complex projects
Ability to communicate and train all levels of the organization
Aptitude to analyze data and prepare reports of findings
Practical application of statistical methods and tools
Advanced knowledge of MS Teams platform
Ability to develop and deliver virtual and in-person presentations and training classes
Advanced knowledge of systems including GXP, BuildingLink, Digital Learning Zone, MHUB, MESH, TrueView, Land-It, Just Report It, Gallup Online, Transcendent, Marriott Asset Library, 4DX, Tableau
Travel 30% to 50%

Job Responsibility

Responsible for implementing property scorecards to measure
Responsible for initiating problem-solving communication with property senior leadership team when necessary, in order to ensure continent success
Responsible for sharing best practices within continent
Responsible for training and development of new property Leaders on Residential specific training including quality tools
Responsible for learning execution including in person and virtual training
Responsible for providing support prior to an opening and leading countdown process for residential openings
Responsible for distribution of digital Personalized Service Flashcards
Responsible for developing and maintaining all scorecards/dashboards
Responsible for auditing and maximizing usage of all systems
Responsible for Owner Engagement Survey sample, daily participation reporting, bi-annual impact plan audit

What we offer

Equal opportunity employer
Rich blend of culture, talent, and experiences
Fosters an environment of inclusion
Dedicated to non-discrimination on any protected basis

Fulltime

Manager, Operations Quality Assurance

This role will work closely with regional and global Compliance, Risk, Product a...

Location

Malaysia; Singapore , Kuala Lumpur; Singapore

Salary:

Not provided

Airwallex

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Accounting, Finance, Economics, Business Management, Statistics and Mathematics, Law or related disciplines
5+ years of relevant experience in financial services, fintech or consulting, with one of the following profiles: Compliance expertise in AML/compliance review and advisory (preferably with CAMS/AAMLP certification)
OR Risk control expertise in credit, fraud, brand and/or consumer risk management
OR QA/Auditing/Consulting backgrounds with strong exposures to compliance testing and risk assessments
Strong understanding of AML/CTF regulations and/or risk management controls, industry practices, and regulatory/card scheme expectations and trends in the financial services, payments, or fintech industries
Familiarity with AML processes (KYC, Transaction Monitoring and Name screening) OR Risk controls (Underwriting, Merchant Risk Monitoring)
Strong communication and time/project management skills
Strong analytical and problem‑solving skills
Fluency in both Mandarin and English (spoken and written)

Job Responsibility

Gain an in‑depth understanding of Airwallex’s product offerings and AML / Risk‑related processes and controls across the end‑to‑end customer and transaction lifecycle
Design and maintain a comprehensive operations QA framework covering compliance, risk controls and key customer-supporting functions to ensure operational standards
Lead a small team of QA analysts and oversee the execution of monthly QA testing, ensuring team productivity and accuracy with high-quality deliverables
Identify operational risks, process gaps and system limitations, determine root causes and impact, and provide suitable recommendations for remediations and enhancements
Communicate QA outcomes clearly and concisely with key stakeholders and senior leadership, and track remedial actions and optimisation opportunities to effective closure
Drive and support global projects and initiatives for operations excellence, providing data‑driven analytics and insights to support informed decision‑making

Fulltime

Senior Manager Quality Assurance: Incoming Quality and Warehouse

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , New Albany

Salary:

144021.45 - 194852.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience
Master's degree and 6 years of Quality/Manufacturing/Engineering experience
Bachelor's degree and 8 years of Quality/Manufacturing/Engineering experience
Associate's degree and 10 years of Quality/Manufacturing/Engineering experience
High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval
Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Lead and participate in Quality Risk Assessments
Provide Quality input to support project or operational design decisions
Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

Fulltime

Quality Assurance Manager

The Quality Assurance Manager is responsible for supporting compliance, safety, ...

Location

United States , Lansing

Salary:

Not provided

Aramark

Expiration Date

Until further notice

Requirements

Bachelor's degree preferred in Business, Hospitality, Safety, Engineering, Operations, Environmental Management, or a related field
equivalent experience considered
3–5 years of experience in quality assurance, compliance, facilities administration, operations support, project coordination, or a related field preferred
Strong organizational and project management skills with the ability to manage multiple priorities simultaneously
Strong interpersonal and communication skills, with the ability to work effectively with both technical and non-technical stakeholders
Ability to interpret contracts, regulatory requirements, policies, and operational procedures
Experience preparing reports, maintaining records, and tracking compliance-related documentation
Demonstrated ability to identify issues, analyze data, and develop practical solutions
Working knowledge of preventive maintenance practices, facilities operations, or asset management systems preferred
Experience with CMMS, compliance tracking, or facilities management software preferred

Job Responsibility

Support property-wide compliance with Aramark standards and applicable federal, state, and local regulations
Coordinate and track required licenses, permits, inspections, certifications, and regulatory reporting obligations
Maintain documentation and records associated with compliance activities, including audit readiness and retention standards
Establish and support recurring internal audit processes and corrective action tracking
Remain current on applicable laws, regulations, and operational requirements impacting the business
Partner with department leaders to ensure Quality Assurance (“QA”) assessments, waste tracking, and related reporting are completed accurately in GMM and other required systems
Implement and maintain department-level Standard Operating Procedures (“SOPs”) through process review, documentation, and ongoing evaluation
Identify operational gaps, process inefficiencies, or non-conformance issues and help develop corrective action plans
Assist in developing reports, dashboards, and tracking tools that support operational performance and compliance visibility
Serve as MS3 Administrator and maintain the MS3 Master Scheduler and Facility Library systems in partnership with Performance Excellence and Project Management teams

Fulltime

Quality Assurance Manager

This is a FlexSteel position and is located in Baytown, TX. FlexSteel (www.flexs...

Location

United States , Baytown

Salary:

Not provided

Cactus Wellhead LLC

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferred
10 years of experience in Manufacturing environment required
5 years of experience in a Quality leadership role required
Experience in Oil & Gas industry preferred
Pre-employment drug screening
Background checks
Medical examinations
Safety certifications
Valid driver's license
Ability to wear personal protective equipment (PPE)

Job Responsibility

Own and maintain the local Quality Management System(QMS) ensuring continued compliance to ISO, API and applicable industry standards
Maintain regulatory compliance with all applicable federal, state and local agencies
Serve as the primary point of contact for internal, and accreditation audits, coordinating audit activities and ensuring successful outcomes
Champion company Quality initiatives and programs and promote excellence in Quality performance
Ensure that Procedures, Specifications and Work Instructions are current, represent best practices and are consistent with the company Quality Management System
Oversee Document Control processes and provide review/approval where required
Provide leadership in ensuring all operations and activities follow company Quality policies and procedures
Maintain Quality metrics and support company reporting mechanisms
With the HSE Manager, facilitate equipment and/or design Risk Assessments and ensure that controls and preventative measures are properly implemented and verified
Willingness to challenge existing processes and escalate quality concerns

Fulltime

Manager, Quality Assurance

CHS is seeking a Quality Assurance Manager to lead and manage food safety and qu...

Location

United States , Fargo

Salary:

86000.00 - 143700.00 USD / Year

CHS Inc.

Expiration Date

Until further notice

Requirements

High School diploma or GED
4+ years of experience in IT Quality Management and/or Quality Management and/or Quality Assurance
Prior leadership experience with progressively advancing level of leadership responsibilities
5+ years of experience in the food industry
4+ years of experience with HACCP and GFSI systems
2+ years of supervisory or management experience
Strong knowledge of FDA regulations, GMP, HACCP, and GFSI standards
Strong leadership and team development skills
Ability to develop and implement SOPs and quality programs
Effective communication across all levels, including regulatory agencies and customers

Job Responsibility

Develop, implement, and maintain facility-wide food safety plans
Ensure compliance with all applicable regulatory, customer, and industry standards
Partner cross-functionally to support operational excellence and business growth
Monitor effectiveness through audit results (e.g., SQF scores)
Design and deliver training programs related to food safety and quality
Train employees on GMP, HACCP, allergens, food defense, and GFSI requirements
Track and maintain training records and compliance
Conduct monthly internal audits (GMP, HACCP, SQF)
Ensures adherence to FDA, Kosher, Organic, and GFSI standards
Ensure completion of corrective and preventative actions

What we offer

medical
dental
vision
wellness programs
life insurance
health and dependent care spending accounts
paid time off
401(k)
pension
profit sharing

Fulltime

Quality Assurance Manager

A growing organization within the pharma /healthcare warehousing space is seekin...

Location

United States , Parsippany

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

5+ years of QA/Compliance leadership experience
Background in pharmaceutical, regulated warehousing, healthcare, or similarly regulated environments
Strong working knowledge of FDA, DEA, OSHA, cGMP, audits, and CAPA
Experience leading client and regulatory audits
Ability to influence cross-functionally in a hands-on, independent role

Job Responsibility

Lead enterprise-wide Quality Assurance and Compliance programs
Ensure compliance with FDA, DEA, OSHA, cGMP, and client-specific requirements
Own client, regulatory, and internal audits from preparation through resolution
Manage CAPA programs, investigations, and effectiveness reviews
Oversee temperature-controlled operations, excursion management, and validation
Ensure inventory integrity, traceability, lot control, and recall readiness
Maintain licenses, certifications, and audit readiness
Drive SOP governance, document control, and training compliance
Lead warehouse safety and compliance initiatives
Partner cross-functionally to identify and mitigate operational risk

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

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Quality Assurance Operations Manager

Job Description

Job Responsibility

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