Capa General Manager Job at Four Seasons (Orlando)

Biological Product Design Owner

This role is responsible for managing technical outcomes through indirect manage...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Relevant technical discipline, preferably an advanced degree in Chemistry/Biology/Chemical Engineering or equivalent
1 up to 5 years of experience with a Bachelor degree or 0 up to 2 years of experience with a Master degree
Excellent communication skills – both written and oral
Ability to work effectively independently and in team environment
Familiarity with applicable quality and regulatory standards for medical devices, drugs and biologics
General working knowledge of standards related to design control, change control, CMC, material qualification, process qualification, validation, and risk management, for biologic drugs
Comfortable in analyzing and solving complex problems within a risk-based approach
Aptitude in managing cross-functional, cross-facility teams and projects of a diverse nature

Job Responsibility

Achieves desired technical outcomes through the indirect management of individuals and teams(s) and the direct completion of complex Design Control, Corrective Action Preventative Action (CAPA), Change Control (CC) projects or programs within the boundaries of timing and budget
Reviews and approves complex design changes with technical staff and provides technical product direction
Provides technical and design-leadership
Fosters an environment of rigor, completeness, and compliance when participating on plant CAPA, CC or Field Corrective Action investigations/assessments
Responsible for technical and project management of a constantly changing initiative portfolio
Responsible for triage escalation to global R&D team members and managing stakeholder expectations
Manages innovative technical solutions to complex product-related problems
Maintains current knowledge of relevant quality standards and regulatory requirements

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Quality Manager

The job was opened specifically for the support of Biostatistics and Programming...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

8-12 years’ experience in clinical research
Demonstrated experience in Quality or Risk Management activities
Expertise in root cause methodologies and CAPA development
Proven leadership in mentoring teams and managing complex, multi-project accounts
Comprehensive mastery of ICH-GCP principles and their strategic application
Fluency in written and oral English
Bachelor’s Degree required preferably in life sciences or health-related discipline or equivalent experience
Advanced degree (master’s degree) in a science, technology or industry-related discipline strongly preferred

Job Responsibility

Quality Event support (Quality Rep role)
audit support
Quality support and consultancy generally worldwide but in particular for the India Biostatistics and Statistical Programming teams
partnering with the India heads of these teams
Support of functional SOP updates
participation in general Quality-related initiatives

Quality & Compliance Team Leader

Yusen Logistics is working to become the world’s preferred supply chain logistic...

Location

United Kingdom , Northampton

Salary:

40000.00 GBP / Year

Webrecruit

Expiration Date

Until further notice

Requirements

Proven previous experience of team management/supervision, with a hand-on approach to coaching & development, as well as experience of HR processes including, appraisals, performance management, recruitment & onboarding, investigations & disciplinaries, & absence management (essential)
Strong complaints management capability, with experience investigating issues and driving timely, compliant resolutions
Previous experience that includes quality assurance in pharmaceutical quality-based roles or logistics quality-based roles
Experience of analytical evaluations
customer service
and complaints management (highly advantageous)
Experience of CAPA management
A strong proactive & continuous improvement mindset, with experience in designing and delivering process improvements
An understanding of Good Distribution Practice (GDP) & MHRA regulations (Medicines & Healthcare products Regulatory Agency)
A strong understanding of Root Cause Analysis methodology

Job Responsibility

GDP Compliance: Applying robust knowledge of GDP guidelines, ensuring the business is fully compliant with required standards & regulatory requirements for the storage & transportation of healthcare products
Take responsibility for ensuring the wider Quality & Compliance team maintain consistency in following the same GDP standards
Provide support on customer audits & discussing SME subjects
Conduct & support internal audits & self-inspections
Raising the audit in the QMS system & raising CAPA’s for any actions required following audit
Compile audit responses & chasing outstanding actions
Complaints Management & Report Writing: Oversee the Quality & Compliance team to ensure that all complaints received from internal and external stakeholders are accurately recorded on the internal EQMS system in a timely manner.
Undertake & support complex case investigations, providing advice and guidance to the Quality & Compliance team, using root cause analysis tools and CAPA management techniques, including liaison with all associated parties, collating documentation and providing evidential reports
Ensure that appropriate investigations are carried out to determine the root cause of complaints and recommended corrective action
Ensure that any potential serious contraventions / complaints are escalated to the Quality & Compliance Manager in a timely manner

What we offer

25 days’ holidays (excluding bank holidays) and 5 days’ Volunteer Leave per year
Opportunity for Unpaid Leave
Critical Illness Cover
MyStrength Wellbeing App
Free online Fitness Platform, i.e. Pilates & Yoga, Mindfulness/Meditation, 24/7 support, advice, diet and Nutrition
On-Site Mental Health First Aiders
Employee benefits, i.e. free eye test, up to 25% off gym membership, high street vouchers
Free access to 24/7 online GP, mental health support service, Life Events Counselling, Care Concierge Service
Tailored development and career opportunities
Karo Health

Fulltime

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Experience working in Quality Function within the Pharmaceutical industry
Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
Basic Knowledge of the Pharmaceutical GxP regulations
Able to foster strong cross-functional relationships
Influence, interpersonal, verbal, and written communication skills
Able to respond positively to, and effectively implement, change
Digitally Savvy
Fluency in both English and Polish to handle communication with healthcare authorities in Poland
A degree or equivalent in a relevant scientific subject is desirable

Job Responsibility

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
Batch Review all MIA Products Prior to QP Certification
Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
Investigation and resolution of complaints with CMOs
Determining and implementing robust CAPAs as required
Assessment and approval of deviations
Managing and approval of change controls
Creation and Maintenance of Quality / Technical Agreements
Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
Support of on-site audits and visits

Senior Quality Assurance Technician

Beacon Hill Life Sciences is looking for an experienced QA professional to perfo...

Location

United States , Maryland Heights

Salary:

28.00 - 30.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

Associate degree in life science or a related field, with completion of 4 college-level life science courses required
Bachelor's degree in life science or a related field preferred
Work experience is considered instead of a degree
3+ years of relevant experience required
Experience with computer data entry required
Must be proficient in Microsoft Office

Job Responsibility

Ensure completion of required training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Responsible for the thorough and efficient review and disposition of completed batch record documentation, ensuring adherence to Good Documentation Practices, cGMPs, and applicable local procedures
Responsible for performing and/or overseeing performance of Quality Assurance 'On The Floor' tasks, including but not limited to performing AQL inspections, performing clearances for manufacturing areas, and providing Quality input and guidance to manufacturing personnel
Responsible for dispositioning finished product, raw materials/ components, and intermediates through an all-inclusive documentation review and cross-reference of electronic quality systems
Responsible for the release of incoming raw materials and components per applicable local procedures. This may include support for labeling dispositioned raw materials and components with appropriate status indicator labels
Ensure a safe and quality working environment through training, awareness, and compliance with safety/Quality guidelines and SOPs
Ensure the maintenance of the department, premises, and equipment
Ensure that all assigned training is carried out so that assigned tasks are performed confidently and consistently
Perform all work in compliance with site safety and radiation protection guidelines

Fulltime

Senior Quality Assurance Technician

Beacon Hill Life Sciences is looking for an experienced QA professional to perfo...

Location

United States , Maryland Heights

Salary:

28.00 - 30.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

Associate degree in life science or a related field, with completion of 4 college-level life science courses required
Bachelor's degree in life science or a related field preferred
Work experience is considered instead of a degree
3+ years of relevant experience required
Experience with computer data entry required
Must be proficient in Microsoft Office

Job Responsibility

Ensure completion of required training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Responsible for the thorough and efficient review and disposition of completed batch record documentation, ensuring adherence to Good Documentation Practices, cGMPs, and applicable local procedures
Responsible for performing and/or overseeing performance of Quality Assurance "On The Floor" tasks, including but not limited to performing AQL inspections, performing clearances for manufacturing areas, and providing Quality input and guidance to manufacturing personnel
Responsible for dispositioning finished product, raw materials/ components, and intermediates through an all-inclusive documentation review and cross-reference of electronic quality systems
Responsible for the release of incoming raw materials and components per applicable local procedures. This may include support for labeling dispositioned raw materials and components with appropriate status indicator labels
Ensure a safe and quality working environment through training, awareness, and compliance with safety/Quality guidelines and SOPs
Ensure the maintenance of the department, premises, and equipment
Ensure that all assigned training is carried out so that assigned tasks are performed confidently and consistently
Perform all work in compliance with site safety and radiation protection guidelines

Fulltime

Senior Analyst, QC Chemistry

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

Location

United Kingdom , Thetford

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Science based degree (preferably in Chemistry, BioChemistry Biology OR Microbiology)
Experience working in a laboratory essential
Demonstrates strong leadership skills
Able to work as part of a team as well as independently
Excellent understanding of Microsoft Office Packages
Is dedicated to meeting the expectations and requirements of internal and external customers
Strong work ethic
Excellent communication skills
Previous experience in a GMP environment/ pharmaceutical QC laboratory

Job Responsibility

Manage and develop direct reports through performance reviews (ACE Check-In) and identify training or development needs
Conduct testing, stability studies, reporting, and checking/reviewing of results in accordance with relevant local and global procedures, testing methods, protocols, and/or pharmacopeial requirements
Ensure direct reports meet safety, quality, and performance standards, and escalate any issues to the QC Manager
Initiate, conduct, and manage quality records, such as deviations, CAPAs, effectiveness checks, and laboratory investigations
Initiate and coordinate document updates, change controls, and successfully manage timelines for implementation of changes
Perform the batch release activities
Participate in internal, customer, and regulatory audits
complete any assigned action items in a timely manner
Perform if required and coordinate general laboratory support activities including housekeeping, equipment maintenance, and inventory of supplies and reagents/ standards
Perform and coordinate calibration checks in accordance with written procedures

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

Senior Analyst, QC Chemistry

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

Location

United Kingdom , Thetford

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Science based degree (preferably in Chemistry, BioChemistry Biology OR Microbiology)
Experience working in a laboratory essential
Demonstrates strong leadership skills
Excellent understanding of Microsoft Office Packages
Previous experience in a GMP environment/ pharmaceutical QC laboratory

Job Responsibility

Manage and develop direct reports through performance reviews (ACE Check-In) and identify training or development needs
Conduct testing, stability studies, reporting, and checking/reviewing of results in accordance with relevant local and global procedures, testing methods, protocols, and/or pharmacopeial requirements
Ensure direct reports meet safety, quality, and performance standards, and escalate any issues to the QC Manager
Initiate, conduct, and manage quality records, such as deviations, CAPAs, effectiveness checks, and laboratory investigations
Initiate and coordinate document updates, change controls, and successfully manage timelines for implementation of changes
Perform the batch release activities
Participate in internal, customer, and regulatory audits
complete any assigned action items in a timely manner
Perform if required and coordinate general laboratory support activities including housekeeping, equipment maintenance, and inventory of supplies and reagents/ standards
Perform and coordinate calibration checks in accordance with written procedures

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

Capa General Manager

Four Seasons

Location:
United States of America , Orlando

Category:
Hospitality and Tourism

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 22, 2026

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