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

The successful candidate will be a proactive professional to support global administrative initiatives. This role entails daily collaboration with 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 filing system for efficient document organization.
• Ensuring technology is functioning, including troubleshooting for staff (e.g., OneDrive, general computer issues) and escalating issues to the IT team when necessary.
• 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.)
• Managing onboarding and offboarding tasks
• Ordering and assigning equipment and managing the return of devices.
• Assisting in recruitment by posting roles, screening candidates and coordinating interviews.
• Planning company events (social events, onsite lunches, Town Hall, Holiday events, etc.)
• Managing company recognition programs (communication, ordering gifts and timely delivery globally)
• Managing budget and purchasing of special items (company swag, lunch, gifts etc.)
• Create and manage creative department content (presentations, email campaigns, etc.)
• 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.
• Perform other tasks and responsibilities as assigned by Manager.

Position Summary

This position will be responsible for planning and overseeing the day-to-day accounting operations of the organization, including, reporting, analysis, and compliance to support our growing company. The successful candidate will have a strong background in accounting, preparing financial documents and leading the finance team. This position will report directly to the CFO.

Responsibilities

• Planning, directing, and coordinating all accounting operational functions
• Managing the accumulation and consolidation of all financial data necessary for an accurate accounting of consolidated business results
• Reducing the time to complete the month end close process
• Prepare quarterly financial presentations for Board Meetings
• Coordinating and preparing internal and external financial statements
• Coordinating activities of external auditors
• Providing management with information vital to the decision-making process
• Managing the annual budget process
• Assessing current accounting operations, offering recommendations for improvement and implementing new processes
• Develop and implement financial policies and procedures as needed
• Evaluating accounting and internal control systems
• Improving the effectiveness of accounting software and supporting database, as needed
• Developing and monitoring business performance metrics
• Overseeing regulatory reporting, including tax planning and compliance
• Coordinating the annual business insurance renewal process ensuring adequate coverage for all risk areas
• Overseeing the day-to-day treasury functions, developing a rolling cash flow forecast to identify financing requirements in advance
• Develop and implement company-wide spending limits
• Manage, mentor, and personally support the finance team

Qualifications

• 3 years or more work experience as a Controller
• Accounting designation required (preferably CPA)
• Ability to perform detailed work and create strategy to advance the department
• Worked in fast paced environment while meeting deadlines
• Excellent written and verbal skills
• Experience working with international subsidiaries
• Remote working arrangement however in-person meetings may be required from time to time
• Supervisory experience (min 5 reports or more)
• Excellent analytical skills and experience implementing, monitoring, and reporting on company metrics
• ERP implementation is an asset

We currently have an opening for a QA Manager  at our US facility. This role will lead the Quality function in our US site and will have one direct report. If you are a personable and proactive Quality professional with experience in clinical trial packaging and labelling, pharma manufacturing or pharma distribution, we would like to hear from you. 

What you will do:

• Quality lead at the New Jersey facility
• Manage all controlled GMP documents
• Initiate and handle EQMS reports (i.e. Deviation, CAPA, Change Control, etc.) reports as required
• Qualify GMP Equipment/Systems/Facilities
• Ensure all regulatory and quality-related documentation is maintained in accordance with relevant SOPs and regulatory requirements
• Plan and conduct required Quality training for all employees (i.e. GMP, SOPs, etc.)
• Provide support for customer and regulatory inspections
• Conduct supplier and customer verification/qualification and approval

Your qualifications, skills and experience include:

• 5 or more years in a QA role in clinical trial packaging and labelling, pharma packaging or pharma distribution
• A degree or diploma from a recognized college or university
• Experience leading and coaching others
• In depth knowledge of FDA and New Jersey Dept. of Health regulations and guidelines
• Knowledge of Health Canada regulations preferred
• Strong written and verbal communication skills
• Ability to prioritize
• Team player who works well with others
• A commitment to providing excellent internal and external customer service