Quality Auditor - Pharmaceutical Job at SQA Services (Milwaukee, WI / Algoma, WI / Janesville, WI / Madison, WI / Neenah, WI / Shawano, WI)

Senior Director Quality Assurance

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , West Greenwich

Salary:

218358.00 - 252850.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
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
Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
Develop area budget, manage expenditure and identify productivity improvement opportunities
Represent ARI Quality in cross-function and cross-site forums

What we offer

A 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
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Global Supplier Quality Senior Specialist

The Senior Specialist, Global Supplier Quality is responsible for driving suppli...

Location

Italy , Pomezia; Milano; Bologna; Alanno

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 7 years’ experience in supplier quality management within pharmaceuticals, medical devices, or food supplements
Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations
Demonstrated success in supplier audits, risk-based quality management, and compliance oversight
Lead Auditor certification highly desirable
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Engineering, or a related technical field
Proven experience using digital tools and systems for supplier qualification and performance management
Exceptional communication, stakeholder management, and problem-solving skills
Ability to operate effectively in a fast-paced, matrixed, and multicultural environment
Fluency in English required
Strong proficiency with Microsoft Office Suite and other business platforms

Job Responsibility

Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards
Develop and maintain comprehensive supplier risk assessments and qualification documentation
Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification
Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards
Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks
Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness
Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews
Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements
Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management
Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity

New

Quality Auditor - Pharmaceutical

This is a contract role performing 1-2 day audits at various suppliers in the Mi...

Location

United States , Milwaukee; Algoma; Janesville; Madison; Neenah; Shawano

Salary:

Not provided

SQA Services

Expiration Date

Until further notice

Requirements

Direct experience auditing to 21 CFR part 210/211
Direct experience auditing to ISO 13485

Job Responsibility

Performing 1-2 day audits at various suppliers in the Midwest

Quality Compliance - Senior Manager

Join Amgen’s Mission of Serving Patients. In this vital role you will be respons...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
12 to 15 years in Pharmaceutical and/or Biotechnology in Quality and/or Manufacturing experience
Lead Auditor Certification
Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
Strong communication skills both verbal and written
Domestic and International travel up to 50%

Job Responsibility

Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers
Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies
Implements risk assessments
Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process
Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings
Serves as subject matter expert on global regulated requirements and inspectional commitments
Provides support for domestic and international Regulatory Authority Inspections when necessary
Provides technical support/compliance review of multi-site/global documents resolving compliance issues
Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations
Alerts senior and/or executive management of significant quality, and compliance risks

What we offer

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Quality Assurance Manager

Are you an experienced Quality Assurance Leader looking for a challenge with a r...

Location

United Kingdom , Stockport

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Proven Leadership/ Management experience in Quality Assurance within a Pharmaceutical (GMP) facility
Degree or equivalent in a relevant scientific discipline
Experience in working with analytical laboratories and/ or GMP production areas

Job Responsibility

Ensure full compliance with UK/EU GMP Regulatory Standards and company procedures
Lead and manage the Quality Assurance Team at an IMP manufacturing site, focused on Phase I and Phase II clinical trial materials
Maintain QA systems and processes, reviewing and supporting ongoing improvement activities
Ensure effective management of documents through life-cycle, ensuring compliance with regulations and industry best practices. This includes - creating, reviewing, and approving key documentation such as specifications, SOPs, protocols, and methods associated with all products and procedures
Support batch documentation review and provide quality oversight for the certification and release of IMPs by the QP
Investigating and approval of deviations, complaints and OOS to prevent future re-occurrences of non-conformance, providing support on SMART CAPA plans
Supplier Management: Managing supplier approval and ongoing performance
Evaluating site compliance and implementing improvements through the internal audit process, as an Internal Auditor and Report approver
Supporting Client projects as a Quality Assurance representative and Customer liaison
Support generation and cascade of quality training packages, including but not limited to GMP induction and annual refresher

Fulltime

New

Quality Director

We are looking for an experienced Quality Director to lead and manage the Qualit...

Location

United States , Dallas

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field
advanced degrees such as M.S. or Pharm.D. are preferred
A minimum of 8 years of experience in aseptic processing and sterile drug manufacturing
At least 5 years of leadership or management experience in a pharmaceutical manufacturing setting
Comprehensive knowledge of 503B Outsourcing Facility requirements, including cGMP principles and sterility testing
Familiarity with USP , USP , and USP standards
Proven track record of successfully managing regulatory inspections and audits
Expertise in state and federal pharmacy regulations related to outsourcing facilities and drug distribution
Strong skills in quality assurance, risk management, and regulatory compliance

Job Responsibility

Lead the Quality Unit to ensure compliance with all regulatory standards for 503B Outsourcing Facilities and sterile drug manufacturing
Oversee quality operations, including aseptic manufacturing processes and wholesale pharmaceutical distribution
Represent the organization during audits and inspections conducted by regulatory agencies and third-party auditors
Manage documentation processes, including batch records, ensuring compliance with cGMP and aseptic protocols
Develop and implement quality systems for deviation management, change control, investigations, and product recalls
Approve validation protocols, qualification reports, and standard operating procedures to meet regulatory requirements
Ensure adherence to guidelines for handling hazardous drugs and sterile preparations
Maintain compliance with state and federal regulations governing wholesale drug distribution
Drive continuous quality improvement initiatives and risk management strategies
Provide technical expertise and leadership in sterile manufacturing and quality assurance practices

What we offer

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

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

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Quality Auditor - Pharmaceutical

SQA Services

Location:
United States , Milwaukee, WI / Algoma, WI / Janesville, WI / Madison, WI / Neenah, WI / Shawano, WI

Category:
Quality Control

Contract Type:
Contract work

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 18, 2026

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