Capa General Manager Job at Four Seasons (Orlando)

New

Executive Director, Facilities & Engineering

Location

United States , West Greenwich

Salary:

243724.00 - 329744.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of experience in an engineering discipline or related technical field OR Master's degree and 10 years of experience in an engineering discipline or related technical field OR Bachelor's degree and 12 years of experience in an engineering discipline or related technical field AND Minimum of 6 years of managerial experience directly leading people within a multi-tiered organization and/or leading teams, projects, programs, or resource allocation activities.

Job Responsibility

Lead the organization responsible for supporting GMP manufacturing operations (24x7x365) while optimizing asset lifecycle management across the site for biologics drug substance manufacturing, warehousing, central utilities, quality control laboratories, process development laboratories, and administrative facilities
Serve as a member of the ARI Site Leadership Team (SLT)
Serve as a member of the Global Engineering Leadership Team (ELT)
Align team vision, mission, strategic objectives, and goals with ARI site priorities and Global Engineering strategies
Foster and sustain a resilient safety culture across the organization
Ensure ongoing compliance and regulatory inspection readiness
Provide technical leadership in assessing emerging industry trends and partnering with vendors to identify innovative opportunities that improve reliability, efficiency, agility, and competitive differentiation
Build and maintain strong relationships with key site and network stakeholders
Ensure active engagement and participation of the ARI site within Amgen global networks
Participate in cross-functional daily management meetings within manufacturing operations, as required

What we offer

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models where possible

Fulltime

New

Support Consultant - Italy, Tier 1

Our ambition in Customer Support is to exceed customer expectations. We provide ...

Location

Ukraine , Kyiv

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Full operational command of English (B2+) and Italian (C1), both verbally and in writing
Previous experience in a support function
Advanced Microsoft Windows (XP, Vista, Win7 etc.) knowledge
General network knowledge incl. understanding the concepts of client-server installations
Database (Oracle and MSSQL) administration knowledge
Customer-oriented approach
Strong technical interest and understanding of IT, software, and engineering problems
Good communicator, with the ability to ask and listen, also to what is not being said
Intercultural competence
User-level knowledge on CRM systems (is a plus)

Job Responsibility

Technical support on 3Shape hardware (3D scanners) and software (CAD/CAM) - via online sessions, telephone, e-mail and occasional on-site events
General support case management: logging, prioritization, troubleshooting (potential escalation), closing, follow-up
Knowledge transfer, input to CAPA (corrective and preventive actions), distributor training
Contributing to 3Shape's business by providing the industry's best Customer Support

What we offer

Meaningful work that helps to change the future of dentistry
Work in a unique professional, friendly and supportive environment
Constant professional growth and development
A healthy work-life balance
24 working days of annual vacation
medical insurance
paid sick leaves and child sick leaves
maternity and paternity leaves etc
Breakfasts and lunches in the office
Good working conditions in a comfortable office in UNIT.City

Fulltime

New

Director, Pharmacovigilance

This is a unique opportunity to join a growing Pharmacovigilance team. This PV e...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV
Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV
Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs
Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments
Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
Experience in the preparation and authoring of pre- and post- aggregate safety reports
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Ability to execute and follow-through to completion and documentation

Job Responsibility

Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s)
Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company
Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs
Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable
Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed
Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings
including coordinating materials, data outputs and presentation, agenda and minutes
Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents
leading cross functional teams to assess safety signals
preparing action and communication plans to mitigate/manage product risks

Fulltime

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Production Lead Technician

Responsible for manufacturing and assembly of clinical and commercial products. ...

Location

United States , Cypress

Salary:

20.00 - 32.00 USD / Hour

Diasorin

Expiration Date

Until further notice

Requirements

Requires High School Degree or higher
Experience working on complex machinery as a Sr. Production Technician or equivalent is preferred
Analytically works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Receives no instructions on routine work, general instructions on new assignments
Good interpersonal and verbal communication skills
Ability to read, analyze, and interpret general, technical procedures, or governmental regulations
Ability to write reports
Ability to effectively present information and respond to questions from groups of supervisors, engineers, or managers
Ability to add, subtract, multiply, and divide

Job Responsibility

Manufacture of subassemblies, components, and/or kits per documented methods
In-process testing of product with ability to interpret results and perform any required adjustments to product
Execute validation protocols and/or experiments
Ability to perform investigation to identify potential root cause of an issue
Ability to identify and implement CAPA (Corrective Action and Preventative Action)
Understand, comply, support, and enforce FDA and ISO regulatory requirements
Understand, comply, support, and enforce all policies and procedures
Lab maintenance per documented cleaning requirements
Inventory maintenance, replenish raw materials and supplies as required
Proper storage of raw materials, subassemblies, components, and kits

What we offer

Health benefits
Retirement and financial wellbeing
Time off programs
Wellbeing support and perks
Annual incentive program

Fulltime

Administrative Assistant

Location

United States , Sacramento

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

2+ years of administrative experience, preferably in a food manufacturing, beverage, or regulated industry
Working knowledge of food safety standards (HACCP, FSMA, GMP, GFSI schemes such as SQF/BRC)
Strong computer skills, including advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and document management systems
Excellent written and verbal communication skills
High attention to detail and strong organizational abilities

Job Responsibility

Provide comprehensive administrative support to the Quality Assurance and Food Safety teams
Manage calendars, schedule meetings, coordinate travel arrangements, and handle correspondence
Prepare, organize, and distribute reports, presentations, and meeting materials
Maintain and update departmental databases, filing systems, and document control procedures
Assist with audit preparation and coordinate internal/external audits
Handle incoming calls, visitor coordination, and general office support
Maintain and organize food safety and quality records, including HACCP plans, prerequisite programs, corrective action reports, and verification documents
Assist in monitoring and tracking compliance with food safety regulations (FSMA, FDA, USDA, etc.)
Support the development, revision, and distribution of Standard Operating Procedures (SOPs) and work instructions
Track and report key quality metrics, non-conformances, and corrective/preventive actions (CAPA)

What we offer

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

Quality Administrator

We are looking for a Quality Administrator to support quality operations for a w...

Location

United States , Horsham

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree in business or a related discipline preferred
At least 1 year of experience or relevant internship exposure in manufacturing, quality, compliance, or administrative support
Familiarity with quality assurance processes and documentation practices in a regulated or manufacturing environment
Exposure to audits, internal audit support, CAPA tracking, or ISO 17025-related activities is strongly preferred
Strong organizational skills with the ability to manage records, deadlines, and multiple priorities accurately
Effective written and verbal communication skills for working with vendors and cross-functional teams
Proficiency with Microsoft Office and general business software tools

Job Responsibility

Coordinate day-to-day administrative support for the company’s quality program and help keep key compliance activities organized and on track
Manage scheduling and recordkeeping for calibration of internal and field testing equipment, working closely with approved service providers as needed
Partner with external vendors and internal stakeholders to arrange quality-related services and monitor completion timelines
Assist in preparing for internal and customer audits by organizing documentation, tracking action items, and supporting follow-up efforts
Maintain accurate quality records, controlled documents, and compliance files to support regulatory and accreditation requirements
Monitor corrective and preventive action activities, document progress, and help ensure timely resolution of assigned items
Support annual training coordination and proficiency testing administration to help maintain readiness across the organization
Contribute to certificate review, contract-related quality documentation, and updates to procedures, policies, and management reports

What we offer

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

Fulltime

Sr Engineer, Quality

The Senior Quality Engineer provides engineering support to the plant through pr...

Location

United States , Hayward

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Strong technical writing, investigation and communication skills required
Experience leading cross-functional teams preferred
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.) Familiarity with MINITAB preferred
Minimum 3 years of experience in regulated manufacturing environment
BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
Applicants must be authorized to work for any employer in the U.S.

Job Responsibility

Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
Supports the manufacturing plant through implementation of process improvements
Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
Leads cross-functional teams
Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
Perform statistical analysis to support Quality and Production
Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
Composes protocols, final reports, studies, experiments and general information reports for use by management

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

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Capa General Manager

Job Description

Job Responsibility

Requirements

What we offer

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