CrawlJobs Logo
Proclinical Logo Proclinical · Quality Control

Quality Compliance Specialist

Switzerland, Neuchâtel · Job Posted March 04, 2026
Apply Position
Job Link Share

Job Description

Proclinical is seeking a Quality Compliance Specialist to join the Quality organization at a facility in Neuchâtel. This role focuses on GMP self-inspection activities, data integrity, and quality project deployment. You will collaborate across departments to ensure compliance with internal standards and regulatory expectations while promoting continuous improvement initiatives.

Job Responsibility

  • Manage and improve the GMP self-inspection system, including planning, execution, and supporting lead auditors
  • Deliver coaching sessions to SMEs and audit teams for inspection readiness
  • Define and implement risk-based self-inspection schedules in collaboration with site leadership
  • Perform gap assessments on new or revised global procedures
  • Coordinate with various departments to ensure alignment and communication
  • Benchmark best practices within the broader Biologics network
  • Support GMP audits by reviewing documents and providing QA input
  • Act as a backroom ACC team member or scribe during audits
  • Prepare and present compliance-related topics at the Quality Council
  • Serve as the local data integrity champion, ensuring adherence to principles through collaboration with global teams
  • Provide compliance support to partners and act as a backup for the Head of Quality Compliance and Systems when needed

Requirements

  • University degree in a technical or scientific discipline (e.g., biochemistry, chemistry, engineering)
  • Strong knowledge of GMP environments and Good Data and Documentation Practices (GDDP)
  • Familiarity with manufacturing, laboratory testing, and warehousing operations for biological products
  • Experience creating, reviewing, and revising SOPs and technical documents
  • Proficiency in French and English (minimum B2 level)
  • Proficiency in electronic quality management systems (e.g., Veeva Vault, TrackWise) and Microsoft Office tools
  • Knowledge of risk management tools and methodologies (e.g., FMEA, root cause analysis)
  • Experience supporting regulatory inspections and audits
Proclinical - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Quality Compliance Specialist

8 matching positions

New

Quality Compliance Specialist

We are seeking a detail-oriented Quality Compliance Specialist to support Qualit...
Location
Location
United States , Bridgewater
Salary
Salary:
40.00 - 47.00 USD / Hour
solomonpage.com Logo
Solomon Page
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree
  • 3–5 years of Quality Assurance or Quality Compliance experience in a regulated manufacturing environment
  • Working knowledge of cGMP, GDP, and Quality Management Systems (QMS)
  • Experience with deviations, CAPAs, change control, and document control
  • Strong organizational, analytical, and communication skills
  • Ability to work independently and collaboratively in a fast-paced environment
Job Responsibility
Job Responsibility
  • Provide QA support for manufacturing operations in accordance with cGMP requirements
  • Review batch records, production documentation, and quality records for accuracy and compliance
  • Support deviations, CAPAs, change controls, and document control activities
  • Perform QA walkthroughs and assist with inspection readiness, internal audits, and regulatory inspections
  • Support product/material release activities and quality oversight
  • Maintain Quality Management System (QMS) documentation and training records
  • Collaborate with Manufacturing, Quality Control, Warehouse, Engineering, and other cross-functional teams
  • Assist with quality investigations, product complaints, and continuous improvement initiatives
  • Perform other quality-related duties as assigned
What we offer
What we offer
  • medical
  • dental
  • 401(k)
  • direct deposit
  • commuter benefits
  • Fulltime
Read More
Arrow Right

Quality Compliance Specialist

Manage, develop, improve and implement the organizational accreditation to ISO13...
Location
Location
United Kingdom , Keele
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Level 6 degree or equivalent in scientific discipline (or 5+ years QMS / QA / auditing role)
  • Worked in a quality / manufacturing environment within a regulated industry
  • 5+ years auditing experience
  • Working knowledge of QMS principles e.g. policies and procedures, regulatory requirements, internal and external audits, risk assessment, CAPA
  • Excellent verbal, non-verbal and written communication skills
  • Accepts responsibility and able to prioritise tasks
  • Car driver
  • Valid Passport
Job Responsibility
Job Responsibility
  • Lead and manage the organizational internal audit program
  • Oversee and mentor internal audit teams, ensuring adherence to deadlines and maintaining high standard of working
  • Lead and manage any third party audits acting as the SME
  • Coordinate and document any investigation and corrective actions relating to internal and external audit nonconformities
  • Develop, improve and write new Standard Operating Procedures and Work Instructions as required
  • Assist in the routine generation of trend analysis and quality data reports and metrics
  • Lead on assigned projects to improve quality/regulatory compliance
  • The support and alignment of internal programs throughout the Biocomposites organizational as directed
  • The role may travelling and often nights away within the UK and on the odd occasion, overseas, to support the audit program
  • Identify and implement additional Quality Management System (QMS) requirements in line with Good Manufacturing Practice (GMP) requirements
What we offer
What we offer
  • Company events
  • Company pension
  • Employee discount
  • Free or subsidised travel
  • Free parking On-site
  • Fulltime
Read More
Arrow Right

Quality Compliance Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...
Location
Location
United Kingdom , Thetford
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in a quality role is essential, ideally in a GMP/ highly regulated environment
  • A scientific degree is desirable but not essential
  • Strategic thinking and problem-solving skills, with a focus on achieving organisational goals through effective training and development initiatives
  • Strong analytical skills
  • Excellent communication and interpersonal skills, with the ability to build relationships and influence stakeholders at all levels.
Job Responsibility
Job Responsibility
  • Compliance of the local quality system (elements specified below)
  • Inspection / audit readiness of the function, including the documentation / records
  • Acting as site SME for Training quality system element
  • Engaging with Stakeholders to understand training needs and develop training solutions and implement training plans
  • Provide coaching and support to trainers and facilitators to enhance their skills and effectiveness
  • Trained as BAXU Super User and Learning Professional and Master trainer for the site
  • Identify opportunities for improvement within the Training function and develop strategies to improve outcomes
  • Change control impact assessments and non-conformance investigations
  • Maintain Employees’ training records
  • Participating in the site internal audit program as Lead Auditor
What we offer
What we offer
  • 25 days annual leave + bank holidays
  • Employee discount scheme
  • Blue light card
  • Progression opportunities
  • Subsided canteen
  • Westfield healthcare
  • Up to 8% pension contribution
  • Employee assistance programme
  • Support for Parents
  • Continuing Education/ Professional Development
  • Fulltime
Read More
Arrow Right

Facility Quality Specialist (Compliance)

As a Facility Quality Specialist (Compliance), you'll support the factory in the...
Location
Location
United States , Allentown
Salary
Salary:
58000.00 - 95000.00 USD / Year
purina.com Logo
Nestlé Purina
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School diploma or GED required
  • 2+ years working in compliance or quality in a manufacturing, industrial, military or related environment
  • Fulltime
Read More
Arrow Right

Quality & Compliance Specialist – Responsible Person (RP)

We are looking for an analytical and driven Quality & Compliance Specialist to a...
Location
Location
Sweden , Helsingborg
Salary
Salary:
Not provided
academicwork.se Logo
Academic Work
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in Life Sciences, Engineering, or a related field required to meet the Swedish regulatory requirements for a Responsible Person (RP)
  • Proven track record in GDP (Good Distribution Practice) and Quality Assurance (QA) within the pharmaceutical industry
  • Experience working with KPI frameworks and the ability to perform "data storytelling" to visualize quality trends
  • Fluency in English is required
  • Proficiency in Swedish is a strong merit
  • Ability to exercise lateral leadership and collaborate effectively across a cross-functional network
Job Responsibility
Job Responsibility
  • Act as the primary point of contact for the Swedish Medical Products Agency (Läkemedelsverket)
  • Ensure compliance with GDP regulations and manage notifications regarding product shortages
  • Implement and maintain local processes for Change Control, Non-Conformances (NC), and CAPA
  • Drive continuous improvement to ensure the QMS remains effective and aligned with business objectives
  • Oversee storage and distribution activities, qualify critical GxP suppliers (e.g., 3PL partners), and establish technical Quality Agreements
  • Define quality requirements for local value-added services such as repacking and relabelling, and approve changes to product artwork
  • Plan and execute self-inspections (internal audits) and provide lead support during Health Authority inspections and external audits
  • Coordinate any product recall operations and ensure that customer complaints are investigated, trended, and mitigated effectively
What we offer
What we offer
  • Possibility to work remote
  • Stora möjligheter att växa professionellt och knyta värdefulla kontakter för framtiden
  • Du får en konsultchef som stöttar dig under resans gång
  • Får ta del av olika förmåner, bl.a. möjlighet till kompetensutveckling i form av en grundläggande hållbarhetsutbildning
  • Fulltime
Read More
Arrow Right

Sr. Quality Specialist, Supplier Quality

Carex is partnering with a Pharmaceuticals industry partner to identify a Suppli...
Location
Location
United States , Madison
Salary
Salary:
Not provided
carexconsulting.com Logo
Carex Consulting Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific field
  • Minimum of 8 years of experience in pharmaceutical or biotechnology quality, including at least 4 years in supplier quality
  • Strong knowledge of FDA, EMA, ICH, GxP, and GDP regulations
  • Experience managing supplier quality systems, including SCARs and change notifications
  • Excellent communication skills with the ability to collaborate across diverse teams and external partners
  • Strong attention to detail, organizational skills, and a proactive problem-solving mindset
  • Experience with electronic document management systems in regulated environments preferred
  • Proficiency with Adobe Acrobat, Microsoft Office, DocuSign, and SmartSheet preferred
  • Ability to work independently, manage priorities, and operate effectively in a fast-paced environment
  • Strong interpersonal, verbal, and written communication skills with a professional approach to external interactions
Job Responsibility
Job Responsibility
  • Manage Supplier Corrective Action Requests (SCARs) and Supplier Change Notifications (SCNs), ensuring timely assessment, resolution, and effectiveness
  • Guide and coach stakeholders on SCAR and SCN processes to promote consistency and strengthen quality culture
  • Support cross-functional evaluation of supplier changes and corrective actions, including impact assessments and follow-up activities
  • Oversee quality agreement lifecycle management, including drafting, reviewing, approving, and maintaining compliance with periodic reviews
  • Assist in establishing and tracking Supplier KPIs and contribute to Quality Management Reviews and Business Review meetings
  • Maintain current knowledge of regulatory requirements and compliance expectations related to drug development
  • Author, review, and maintain procedural documentation such as SOPs, work instructions, policies, and forms
  • Support regulatory inspections as a subject matter expert
  • Ensure compliance with cGMP, 21 CFR, USP, EP, and ICH standards
  • Perform additional responsibilities aligned with the role as needed
  • Fulltime
Read More
Arrow Right

Sr. Quality Specialist, Clinical Quality

Baptist Health is hiring a Sr. Quality Specialist to join the Quality team. This...
Location
Location
United States , Jacksonville Beach
Salary
Salary:
Not provided
baptistjax.com Logo
Baptist Health (Florida)
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree - Nursing
  • 3-5 Years Clinical Nursing Experience Required
  • 1-2 years Healthcare Quality Required
  • Basic Life Support (BLS) Required
  • Licensed Registered Nurse Required
  • Must be a registered nurse
Job Responsibility
Job Responsibility
  • Oversees and/or works in tandem with facility-based quality improvement program team and leaders
  • Establishes facility quality procedures, standards, and specifications
  • assesses needs and compliance
  • Advances novice quality team members to proficient quality team leaders through ongoing mentorship, communication, and support
  • Aligns with the National Association of Healthcare Quality's 8 domains for healthcare quality competency
  • Actively engages in healthcare quality development through competence and continued learning
  • Collaborates with Facility Leaders to promote and incorporate healthcare quality objectives into the strategic operating practices through professional communication and relationship building
  • Interacts and establishes relationships with System Leadership and Boards in partnership with Advanced Quality Team Members
  • Adopts and utilizes performance improvement frameworks and methodologies to lead projects and change management at the local facility level
  • Begins leading and/or co-leading projects and/or committees at the healthcare system level
  • Fulltime
Read More
Arrow Right

Technical & Quality Centre Quality Product Analysis Specialist

The Quality Product Analysis Specialist plays a critical role within the Technic...
Location
Location
United Kingdom , Rotherham
Salary
Salary:
Not provided
napaonline.com Logo
NAPA Auto Parts
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven Experience: Ideally 3–5 years as a senior technician or diagnostic specialist in a high-volume garage, remanufacturing environment, or warranty inspection role
  • Certification: Level 3 Automotive Technician qualification or equivalent (e.g., IMI or City & Guilds)
  • Failure Analysis Training. Warranty Training: Experience or formal training related to warranty claim evaluation and processing preferred
  • Multi-System Mastery: Deep mechanical knowledge of modern vehicle and electronic systems
  • Electrical Proficiency: Ability to read electrical schematics and use multimeters or oscilloscopes to test rotating electrics and electronic sensors
  • Software Literacy: Comfortable with PC-based diagnostic software, CRM portals, warranty management systems, and standard office tools (e.g., Microsoft Word/Excel)
  • Precision Measurement: Skilled with precision tools such as micrometers, vernier calipers, and dial indicators for checking tolerances and shaft play
  • Warranty & Compliance Knowledge: Understanding of warranty policies, claim processing procedures, and applicable regulatory standards
  • Analytical Thinking: Logical, detective-like mindset adept at solving complex diagnostic puzzles that other technicians may overlook
  • Attention to Detail: Precision in inspecting fracture surfaces, wear patterns, and minute electrical deviations
Job Responsibility
Job Responsibility
  • Component Inspection: Conduct detailed physical and functional inspections on a wide range of components including turbos, braking systems, suspension units, clutches, and rotating electrics (alternators/starters)
  • Diagnostic Testing: Operate specialised test equipment (e.g., vacuum testers, electronic actuator testers, battery/alternator analysers, brake DTV machines, and brake caliper testers) to verify part performance against factory specifications
  • Root Cause Analysis: Investigate and determine the underlying cause of failure (e.g., carbon buildup, oil starvation, electrical surges, installation errors) to support warranty claim evaluations
  • Warranty Claim Assessment: Review and assess warranty claims in accordance with company policies, determining validity and identifying potential manufacturing or usage defects
  • Digital Reporting & Documentation: Utilise computer systems to log findings, upload digital photos of defects, generate professional inspection and warranty evaluation reports, and maintain accurate records for claim processing
  • Quality & Compliance: Maintain a clean, organised laboratory/testing environment ensuring all test equipment is in safe and calibrated working order. Ensure inspections comply with company standards and relevant regulatory requirements
  • Cross-Functional Communication: Collaborate closely with warranty administration, customer service, and re manufacturing teams to share findings, explain technical details, and support timely claim resolution
What we offer
What we offer
  • We offer comprehensive benefit plans and programs designed to support your health and wellness, provide income protection and build financial security for your retirement
Read More
Arrow Right