Careers

We are currently looking for a Quality Manager - EU to join our growing team. If you are a seasoned Quality professional with leadership experience in the CTS, secondary packaging and labelling or pharmaceutical industry, this might be the role for you.

The Quality Manager - EU will be appointed by the RxSource Executive Team as the Management Representative to oversee all activities in the Quality department within Europe and will ensure the implementation and continued development of the Quality Management Systems of all RxSource Limited divisions (Sourcing, Clinical Trial Services, Distribution, Medical Devices, and Regulatory Affairs). The person in this role will work closely with the global QA team to ensure processes are harmonised across the three RxSource sites.

This is a pivotal leadership role that requires the candidate to have proven Quality experience, strategy, strong communication and analytical skills to fulfill RxSource’s vision, mission and values.

What you will do:

• Maintain compliance to all relevant standards and legislative requirements pertinent to EU regulations
• Foster, lead and embed a strong culture of quality in RxSource Limited
• Lead and develop the quality team at the Ireland location
• Work with the global QA team to implement an Electronic Quality Management System and continued development of Integrated Management Systems
• Manage regulatory, customer and vendor inspections
• Ensure that initial and continuous training programs are implemented and maintained within all divisions of the organisation
• Manage the Change Control process, ensuring controlled implementation of all GxP related changes in accordance with relevant SOP’s
• Review and approve Corrective and Preventive action (CAPA), including tracking, follow-up, and evaluating CAPA effectiveness.
• Lead and manage the QA responsibilities under the Manufacture and Importation Authorization (MIA) including Qualified Person (QP), ensuring implementation and continued development of the quality system and good manufactures practices (GMP)
• Lead and manage the QA responsibilities for the Packaging and Labelling activities, ensuring implementation
• Conducts validation/qualification of GMP Equipment/Systems/Facilities
• Communicate frequently with all the departments to ensure information flows seamlessly (QA, Logistics, Project Management, Sourcing, Purchasing, Operations, HR and Regional Teams etc.)

Your experience, skills and qualifications:

• 3+ years of QA experience in clinical trials, pharmaceutical or medical devices
• Solid knowledge of European regulations and guidelines
• A Diploma or Degree from a recognized College or University or equivalent working experience
• Proficient in MS Office - including Outlook, Word, Excel, PowerPoint, OneNote, Teams
• Supervisory experience preferred
• Experience working with Electronic Quality Management Systems (e.g. TrackWise, etc.)
• Professional level grammar and excellent proof-reading skills
• Excellent communications skills (verbal, written, listening, conveying messages)
• Detail-oriented
• Solid decision-making skills
• Highly adaptable, flexible professional who embraces teamwork, but also enjoys working independently
• Experience working with colleagues across different Global time zones
• Willingness and flexibility to travel as required

Position Summary

The ideal candidate will be responsible for planning, coordinating, and implementing projects within the decided-upon budget, timeline, and scope. They will also effectively monitor and present project updates to relevant stakeholders, clients, or project team members.

Responsibilities

• Act as the primary point of contact for the client and facilitate responses and coordination
• Support proposal requests for new business opportunities and change order requirements
• Internal and external project initiation, administration, and activation activities
• Coordination and facilitation of internal and external project meetings, such as scheduling, leading the meetings, and drafting meeting agendas and minutes, etc.
• Active management of project scope, budget, timelines, and other project deliverables with project team and external stakeholders
• Set up and coordination of project plan and delivery timelines, such as drafting Project Specification Overview, label design, packaging specification forms and other project documents required to successfully execute project deliverables
• Working with Operations to schedule the planning of packaging and labelling runs, review relevant documents for each run e.g. batch record
• Facilitate ad-hoc requests to coordinate and follow up on critical path project execution tasks
• Responsible for planning and reporting on Project Management activities
• Supports financial and project performance management activities
• Identify new best practices and document efficient processes
• Provide leadership and mentoring to team members
• Liaise with qualified suppliers, providing relevant information to client to service project deliverables
• Responsible for conducting research on product information, availability, pricing, and strategy implementation
• Responsible for maintaining CRM data integrity which includes, but is not limited to; Creating and/or updating, product information, pricing, and costing
• Responsible for the fulfillment of client orders, ensuring accuracy, profitability and customer satisfaction
• Collaborate effectively with other departments
• Perform other duties as required to ensure the continual development of the Project Management teams

Qualifications

• Minimum 3 years of experience working within Project Management
• A Diploma or Degree from a recognized College or University or equivalent working experience
• High level of business acumen, problem solving, negotiation, time management and multitasking
• Highly ambitious and motivated
• Computer literacy, proficient in MS Office suites and CRM systems
• Strong written and verbal communication. Multi-lingual considered an asset
• Strong analytical skills and the ability to learn and adapt easily to changes
• Works well independently, as well as part of a team
• Knowledge of pharmaceutical industry is preferred

No matter your role at RxSource, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Achievers, who drive toward practical solutions
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality and accountable executors, working towards goals and milestones with quality, precision, and speed

Position Summary:

We are seeking an experienced HR Generalist who is a team player and can support the company’s HR initiatives while enhancing our employee culture. The successful candidate will have experience in all the main HR functions including – talent acquisition, employee relations, health & safety, performance management and benefits. Currently, this role is mainly remote with a requirement to be in the office occasionally (1-2 times per month). This is a 14-month contract position to cover a maternity leave.

What you will do:

• Handle day to day activities related to talent acquisition, employee relations, performance management, health & safety and benefits
• Assist in driving employee engagement through initiatives such as corporate communications, town halls and corporate events, and employee pulse surveys.
• Make recommendations for improvement to ensure ongoing compliance with legislative requirements for our global team (i.e. Human Rights Code, Employment Standards, Health and Safety and personal data laws)
• Ensure employee records are maintained, updated and are confidentially stored.
• Oversee and administer the employee performance review program including support for managers, coaching and feedback to staff
• Advise on employee relations matters (incidents, investigations, Health and safety etc.)
• Lead the full cycle recruitment process
• Handle all administrative tasks related to onboarding and offboarding including data management, task management, auditing for accuracy and compliance
• Manage all benefit programs globally
• This position has 1 direct report.

Your Skills, Experience and Qualifications:

• A minimum of 5 years’ proven experience in a similar role
• CHRP (Certified Human Resources Professional) designation is considered an asset
• HR Diploma or Degree from a recognized College or University or equivalent working experience
• Strong knowledge of Ontario employment and health and safety legislation along with the ability to interpret and understand HR related legislation in other countries where we have employees (USA and Europe)
• Ability to write and communicate clearly and effectively
• Solid business acumen, problem solving, negotiation, organization, and multitasking skills
• Computer literacy, proficient in MS Office suites and HRIS systems
• Ability to prioritize and meet deadlines in a fast-paced environment
• Willingness to work within different global time zones
• Ability to work independently and manage time effectively

No matter your role at RxSource, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Achievers, who drive toward practical solutions
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality and accountable executors, working towards goals and milestones with quality, precision, and speed