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

Qualified Person

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

United Kingdom , Oxford

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

A Life Science degree and/or relevant postgraduate qualification, with a minimum of 10 years’ experience in quality roles within the biotechnology and/or pharmaceutical industry
Eligibility to act as a Qualified Person (QP), with demonstrable knowledge of biologics and sterile manufacturing sufficient to be named on the site’s licences issued by the MHRA
Commitment to maintaining QP status through ongoing Continuing Professional Development
Experience working in GMP-regulated pharmaceutical / biological manufacturing environments
Expert knowledge of Pharmaceutical Quality Management Systems, including their application across the product lifecycle
Extensive understanding of GxP requirements for both early-phase clinical trial materials and commercial products, including interpretation and application of EU GMP and associated MHRA guidance
Demonstrated, in-depth understanding of broader GMP principles, industry standards, and current trends shaping the regulatory landscape
Experience as a qualified pharmaceutical auditor (internal and/or external)
Proven experience hosting and participating in regulatory inspections (e.g., MHRA, FDA, EMA)
Demonstrated ability to influence cross-functional teams, provide leadership and drive organisational change.

Job Responsibility

Acting as the named Qualified Person (QP) on Moderna’s site licence(s)
Certifying and authorising batch releases in full compliance with The Human Medicines Regulations 2012, EU GMP (Annex 16, and where applicable, Annex 13), and MHRA guidance
Ensuring sterile drug product batches meet cGMP, approved specifications, and the conditions of the Marketing or Clinical Trial Authorisation
Maintaining oversight of the PQS as it pertains to QP responsibilities, ensuring it is fit for purpose
Escalating GMP or product quality concerns related to safety and efficacy to senior leadership
Participating as a member of the site and country Quality teams, promoting strong quality culture and QRM principles
Attending and reporting at the Quality Management Review Forum
Overseeing delegated activities and ensuring proper training of personnel or third parties
Leading or participating in self-inspections, external audits, and Quality Risk Assessments
Serving as the QP point of contact for Technical/Quality Agreement reviews and approvals

What we offer

Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future

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

Auditor, Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States of America , Guayama

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in science or related field with three (3) to five (5) years' experience
Fully Bilingual - written and spoken English and Spanish
Strong cGMP knowledge, 21 CFR Part 11, 210 and 211, ICH Q7A, Eudralex and other applicable to API and FG anesthetics
Professional License or Certification Required: Lead Auditor Certification

Job Responsibility

Leads internal audit program and readiness for the external inspections
Conduct assessments adhering to the approved internal audit schedule using the applicable Baxter Quality Manual, division and/or local procedures, applicable regulations, standards, inspection guidelines and compendial requirements
Lead the planning and development of assessment strategy and logistics for Internal and External Audits
Coordination and execution of the yearly audit schedule
Conduct audits/assessments by researching background information, including previous internal/external audit results, applicable regulations and standards as well as local and global standard operating procedures
Collect and analyze objective evidence regarding issues and risk
report findings (verbally and written) to management
Audit System Management Review presentation
Evaluate observations responses and CAPA action plan for adequacy, including risk impact, root cause, timeliness and effectiveness
Maintain audit file through the process up to audit closure

What we offer

Medical, Dental, Disability and Life Insurance coverage
Vision Plan
Paid Vacation Days and Paid Holidays
Paid Parental Leave
Retirement Plan 165e
Employee Stock Purchase Program
Educational Assistance Plan
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits

Fulltime