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

As a key member of the USA Quality Team, this individual will be supporting critical processes within the Quality Management System to ensure compliance to applicable standards. The Ideal candidate will be detail orientated, with working knowledge of GMP’s. This individual will have strong communication skills and be highly adaptable to changing work environments to fulfil RxSource’s vision, mission and values.

Responsibilities:
• Conducting quality checks on incoming and outgoing products in accordance with RxSource’s established Standard Operating Procedures (SOPs)
• Performing Good Manufacturing Practices (GMP) sampling and inspection of Clinical Trial materials, drug products, packaging and label materials
• Performing In-Process Checks for Secondary Clinical Trial Packaging and Labelling (P&L) activities
• Performing and documenting investigation of damaged material and discrepancies in the distribution records
• Reporting any non-conformities, defects, or problems to the site’s Quality Team
• Prepare and maintain retention samples when necessary
• Providing project and/or process support for the Quality Department
• Reporting and documenting any temperature excursions, returned goods, customer complaints, recalls, products for destruction, and any other issues that may impact the quality and integrity of the products
• Assisting production team to conduct and document Clinical Trial P&L runs
• Monitoring and ensuring that the environmental conditions are met as per GMP requirements

Qualifications:
• College Diploma with 2+ year of experience working in the quality field
• Knowledge of Irish regulations and guidelines
• Computer literacy, proficiency with MS Office - including Outlook, Word, Excel, PowerPoint, OneNote, Teams
• Experience working with Electronic Quality Management Systems (e.g. TrackWise, etc.) is an asset
• Excellent communications skills (verbal, written, listening, conveying messages)
• Detail-oriented
• Ability to work well under pressure
• Solid decision-making skills
• Highly adaptable, flexible professional who embraces teamwork, but also enjoys working independently

The Global Lead, Sales and Marketing position is accountable for creating and executing a global sales and marketing strategy focusing on our Clinical Trial Supply services to achieve significant year-over-year growth.  This is a strategic role and will work in collaboration with the Executive Leadership Team. 

Accountabilities: 

 •                  Formulate the 3-to 5-year Sales and Marketing plan with a clear picture of outcomes, metrics, etc., and share it with LT.

•                  Build a business pipeline focusing on our core services and target market for new and existing clients.

•                  Develop, train and provide leadership to the Business Development, Proposal Writing and Marketing team.

•                  Create processes and systems to ensure optimal efficiency from lead generation to new client orders.

•                  Lead the Sales and Marketing department by setting objectives, budgeting and staffing to effectively support the organization's goals and growth.

•                  Reading, writing and approving Service Level Agreements and Contracts

•                  Creating and presenting client decks

•                  Bid Submission and Defence

•                  Comfortable learning technology

•                  Provide regular updates to the ELT with reports and analysis

•                  All other related accountabilities for this executive leadership role  

Qualifications: 

 •                  Minimum 5 years experience at an executive level in leading Sales and Revenue

•                  Proven history of scaling organizations for growth and development in CTS (secondary packaging and labelling, storage and distribution, and sourcing)

•                  Experience removing obstacles and taking full accountability for plan and execution

•                  Understanding the full sales cycle with excellent presentation and negotiation skills, selling value vs. discounts

•                  Strong leadership and organizational skills, with the ability to inspire and lead teams towards excellence.

•                  Excellent communication and interpersonal skills, with the ability to interact effectively with all levels of the organization and external partners.

•                  Detail-oriented, analytical, and able to manage multiple tasks in a fast-paced environment.

•                  Knowledge of pricing for our services to remain competitive

•                  Great network of clients, vendors and people to influence growth 

The successful candidate will be a proactive professional to support global administrative initiatives. The Administrative Associate role entails daily collaboration with the Corporate Services Team, Senior Management and other departments. The ideal candidate will be able to work within sensitive timelines, exercise a high level of confidentiality and be required to accommodate various time zones. This is a remote position with occasional requirements to be on-site.

Responsibilities:

•         Demonstrate discretion when handling sensitive information.
•         Manage a comprehensive electronic filing system for efficient document organization.
•         Oversee administration tasks within the three facilities (Canada, USA, Ireland).
•         Coordinate international travel arrangements for employees, including booking, itinerary development, and resolving time-sensitive travel conflicts promptly.
•         Planning and coordinating company events (social events, onsite lunches, Town Hall, Holiday events, etc.)
•         Coordinating company recognition programs (communication, ordering gifts and timely delivery globally).
•        Assist with managing the budget and purchasing special items (company swag, lunch, gifts etc.)
•         Create and distribute corporate communications (staff email notices, presentations, creative email/MS Teams campaigns, etc.)
•         Assisting in recruitment activities by posting roles, screening candidates, and coordinating interviews.
•         Contacting references and performing background checks on candidates.
•         Assist with onboarding and offboarding tasks.
•         Tracking, assigning, and ordering equipment and managing the return of devices.
•         Act as a liaison with external service providers, such as IT contractors and other relevant partners.
•        Keep third-party services up to date and ensure timely payment (LinkedIn, SurveyMonkey, phone systems, internet etc.)
•         Assigning licenses for corporate products (Microsoft, Adobe, Zoom, Grammarly etc.)
•         Assisting to ensure technology is functioning, including troubleshooting for staff (e.g., OneDrive, general computer issues) and escalating issues to the IT team when necessary).
•         Perform other tasks and responsibilities as assigned by the Manager

Qualifications and Requirements:

·        3+ years of experience in the administrative roles.

·        Experience as an Executive Assistant is considered an asset.

·        Diploma or Degree from a recognized College or University or equivalent working experience.

·        Proficient in MS Office Suite, including Outlook, Word, Excel, PowerPoint, OneNote, Teams etc.

·        Experience with Canva and the ability to create some internal promotional content.

·        Tech-savvy with troubleshooting abilities to assist our global team with computer-related issues.

·        Excellent written and verbal communication.

·        High level of business acumen, problem-solving, negotiation, time management and multitasking.

·        Creative thinking and the ability to think outside the box.

·        Ability to perform accurately in a fast-paced under minimal supervision.

·        Willingness to work within different global time zones.

·        Flexibility to travel to Richmond Hill when required.