Cqa Job at Randstad (Shanghai)

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

Principal Supplier Quality Engineer

This position provides technical leadership for Supplier Quality Management proc...

Location

United States

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.
B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry.
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques.
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor

Job Responsibility

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements.
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers.
Establish and administer the supplier audit program for quality/regulatory compliance.
Maintain the Approved Supplier List (ASL).
Support the Global Supplier Review Board, including providing metrics for supplier assessments.
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits.
Provide guidance as needed for corrective action required because of assessment findings.
Execute supplier audits in accordance with approved schedules.
Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes.

What we offer

comprehensive and competitive range of benefits
Total Rewards package
pay
health care benefits
retirement plans
work/life benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria

Geotechnical Projects Manager

Lead. Innovate. Shape the Ground Beneath Our Future. We’re looking for an influe...

Location

United Kingdom , Preston

Salary:

60000.00 GBP / Year

McCarthy Recruitment

Expiration Date

Until further notice

Requirements

Degree in Geotechnical, Civil, Environmental Engineering, or similar
Proven geotechnical design experience with strong CQA and earthworks background
Confident user of AutoCAD and Civil 3D
Strong leadership of junior engineers, technicians, or surveyors
Skilled communicator with excellent technical writing capability

Job Responsibility

Drive geotechnical design for foundations, slopes, earthworks, and ground improvement
Oversee and review CQA validation for landfills, engineered slopes, and bulk earthworks
Direct ground investigations, interpret soil/rock data, and prepare high-quality technical reports
Ensure all ground engineering outputs are technically sound, compliant, and commercially effective
Lead on-site quality monitoring — including compaction, lining systems, and material compliance
Produce precise, professional CQA validation reports aligned with regulatory and design standards
Support environmental and engineering compliance on all earthworks and infrastructure schemes
Manage topographic, boundary, drone, and as-built survey workflows
Ensure complete integration of survey outputs into design, CQA, and volume calculations
Champion innovation in drone technologies, photogrammetry, and digital data capture

What we offer

Car

Fulltime

Associate Director, Clinical Quality Assurance

We are seeking a dynamic and results-driven Associate Director of Clinical Quali...

Location

United States

Salary:

170000.00 - 190000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus
8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function
Minimum of 6 years of direct audit experience in GCP
In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements
Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators
Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change
Excellent problem-solving and critical thinking abilities
Flexible and creative to meet the needs and challenges of a growing, dynamic company
Focus on fostering a culture of collaboration and teamwork
Ability to manage multiple projects with aggressive timelines and changing priorities

Job Responsibility

Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs
Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision
Act as CQA lead representative at clinical study team meetings and other study related meetings
Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP
Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence
Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned
Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization
Assist in the development and/or delivery of GCP training topics and quality standards as directed
Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals
Collaborate with clinical functions to support inspection readiness activities

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Associate director lead gcp clinical quality assurance

Responsible for execution and performance of Lantheus CQA quality system element...

Location

United States , Remote

Salary:

139000.00 - 232000.00 USD / Year

Life Molecular Imaging

Expiration Date

April 15, 2026

Requirements

Bachelor’s degree in a scientific discipline preferred
Minimum 7 years’ experience in the pharmaceutical or biotech industry with five (5) or more of those years in GCP Clinical Quality Assurance
Proficient understanding of ICH GCP and appliable CFR regulations with a working knowledge of cGLP
Experience providing GCP Clinical Quality Assurance guidance to Clinical teams for assigned Programs/Trials
Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials
Experience in conducting internal and external GCP audits (Ie. Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process
Ability to manage processes with continuous improvement approach
Analytical and critical thinking skills
Diplomatically work and collaborate cross functionally at all levels within the organization
Excellent communication (Oral and Written), planning, coordination, and time management skills

Job Responsibility

Serve as the CQA lead for assigned trials and assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/cGLP
Development and execution of a risk-based clinical quality audit plan for assigned programs
Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data as needed
Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and cross-functional groups
Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections and perform effectiveness checks
Author audit reports and coordinate supporting documentation
manage same in QMS
Peer review reports authored by colleagues
Identify non-compliance trends and systematic risks for assigned areas of responsibility
Contribute to the development, maintenance, and continuous improvement of the quality system processes, tools, and E-Systems

What we offer

Discretionary performance-based cash incentive
Discretionary annual equity award (depending on level)
Comprehensive health benefits package (medical, prescription drug, dental, and vision coverage)
Life and disability benefits
Pre-tax accounts
401(k) with company contribution
Generous time off package (paid vacation, holidays, sick days, and paid parental leave)

Fulltime

New

Regional Quality Manager

The Regional Quality Manager plays a critical role in ensuring that Trivium prod...

Location

United States , Roanoke

Salary:

Not provided

Trivium Packaging

Expiration Date

Until further notice

Requirements

Bachelor’s degree in relevant discipline. Or Associate degree with minimum 5 years in quality management and/or customer technical service experience
Experience with metal can quality manufacturing operations
Demonstrated experience managing external customer relationships in a technical or quality‑driven environment
Proven track record in process improvement, transformation initiatives, and standardizing ways of working
Experience working cross‑functionally with Sales, Operations, Quality, and R&D
Experience influencing internal and external stakeholders at multiple organizational levels
Strong people‑leadership skills, with experience managing teams (both direct reports and matrix environments)
Demonstrated ability to lead through influence, drive change, and coordinate cross‑functional activities
Ability to organize, prioritize, and allocate workload across a regional technical team
Six Sigma Black Belt or Green Belt Certification preferred

Job Responsibility

Strategically plan and lead regional customer‑engagement quality strategy working closely with Commercial team strengthening relationships enabling early quality response and preventing issues
Align Quality, Commercial, and CTS priorities to maximize customer support and ensure consistency with commercial strategy and objectives
Provide customer and market insights that shape long‑term quality, product, and process improvement initiatives
Drive regional quality and compliance including HARA and GFSI packaging standards as per customer requirements
Champion customer satisfaction and continuous improvement across all manufacturing sites
Translate customer inputs into actionable plant projects and quality improvements
Guide plants in meeting specifications and customer requirements consistently
Lead quality improvement and risk‑reduction initiatives using FMEA and other risk assessments
Act as primary contact for customer and third‑party audits, ensuring timely and effective corrective actions
Partner with Commercial, Product Development, and Engineering on new business, trials, and qualifications

New

Environmental Site Engineer

We’re recruiting an Environmental Site Engineer to support construction quality ...

Location

United Kingdom , Warrington

Salary:

40000.00 GBP / Year

McCarthy Recruitment

Expiration Date

Until further notice

Requirements

Degree in Civil, Geotechnical or Environmental Engineering (or similar)
Experience in earthworks, geosynthetics, landfill engineering, or site QA/QC
Good understanding of geotechnical principles and construction quality
Strong reporting, communication, and documentation skills
Willingness to travel and work across multiple sites

Job Responsibility

Monitor and supervise construction works to ensure compliance with drawings and specifications
Oversee field and laboratory testing (e.g., compaction, permeability)
Check materials, workmanship, and escalate issues where needed
Produce daily site records and contribute to CQA plans and validation reports
Communicate with contractors, designers, regulators and stakeholders
Support the delivery of safe, compliant, and high‑quality engineering projects across the region

What we offer

company vehicle

Fulltime

New

Manager - Oncology RWE Statistical Programming

Amgen is seeking a dedicated Biostatistical Programming Manager to join our Cent...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least six (6) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
Proficiency in SQL programming and SAS or R programming is required
Scientific and technical excellence
Exceptional oral and written communication skills
Problem-solving abilities
Meticulous attention to detail
Ability to work effectively within a large, globally distributed team

Job Responsibility

Provide technical solutions to programming problems within CfOR
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Project manage programming activities, according to agreed resource and timeline plans
Ensure programming activities adhere to departmental standards and SOPs
Write and/or review and approve programming plans
Write and/or review and approve analysis dataset specifications
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
Write, test, validate and execute department-, product- and protocol-level macros and utilities

Cqa

Randstad

Location:
China , Shanghai

Category:
-

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 26, 2026

Expiration:
June 03, 2026

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Cqa

Randstad

Location:China , Shanghai

Category:-

Contract Type:Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 26, 2026

Expiration:June 03, 2026

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