Careers

osition Summary:

The QA Manager & Qualified Person (QP) is the senior Quality representative at the Dubin, Ireland facility and is responsible for the effective implementation, maintenance, and continuous improvement of the site Pharmaceutical Quality System (PQS) locally. This role provides quality oversight of GMP/GDP operations supporting packaging, labeling, QP certification, and distribution of investigational medicinal products (IMPs) in support of clinical trials.

In addition, this role performs Qualified Person (QP) duties in accordance with EU GMP, Annex 13, Annex 16, the Manufacturing/Importation Authorization (MIA), and applicable EU and national legislation, certifying IMP batches for release for clinical trial use.

The role serves as the primary site Quality lead, supporting inspections, audits, supplier qualification, quality events management, and training, while partnering cross?functionally to embed a strong culture of quality and compliance. On?site Quality personnel will report to the QA Manager & Qualified Person (QP).

Responsibilities: 

QA Manager Responsibilities:

• Ensure ongoing compliance with EU GMP, GDP, HPRA expectations, and internal SOPs.
• Maintain and continuously improve the site Pharmaceutical Quality System (PQS).
• Act as Quality lead for the Dubin facility, providing daily QA oversight of operations.
• Review and approve controlled documents such as SOPs and work instructions.
• Provide QA oversight for clinical trial related services, including receipt, storage, label printing, secondary packaging and labeling, and distribution of products used in clinical trials.
• Review and approve clinical packaging and labeling batch documentation.
• Provide QA oversight of activities such as temperature monitoring, sanitation, environmental controls, calibration, and preventive maintenance.
• Ensure GMP/GDP facilities, systems, and equipment maintain a qualified/validated state.
• Review, approve, and manage deviations, CAPAs, change controls, risk assessments, complaints, and investigations within the EQMS ensuring data integrity and timely closure.
• Lead or support root cause investigations and ensure timely, effective corrective and preventive actions.
• Support and execute product recalls in accordance with SOPs and legal/regulatory guidance when required.
• Host and support customer audits, regulatory inspections, and internal self?inspections.
• Ensure inspection readiness and timely, compliant responses to audit observations.
• Serve as a Quality point of contact for customers and regulatory authorities as needed.
• Qualify, assess, and monitor suppliers and service providers using a risk-based approach.
• Review and maintain Quality Agreements / Technical Agreements with suppliers and customers.
• Develop, deliver, and oversee GMP/GDP and SOP training programs and assess training effectiveness.
• Assess training effectiveness and identify ongoing training needs.
• Assist in recruiting, onboarding, coaching, and mentoring Quality team members.
• Promote a proactive quality culture across all functions and levels.
• Drive continuous improvement initiatives to enhance compliance, efficiency, and quality performance.
• Track, trend, and report quality metrics to senior management and support management review activities.
• Stay current with changes in US and global pharmaceutical regulations, guidance, and industry best practices.

Qualified Person Responsibilities:

• Act as a named Qualified Person on the site MIA and perform QP duties as defined in site SOPs and Quality Agreements.
• Certify and release IMP batches in accordance with EU GMP, Annex 13, Annex 16, CTA/IMPD requirements, and national legislation.
• Ensure that all manufacturing, testing, packaging, and supply chain activities comply with EU GMP and the approved clinical trial authorization.
• Verify that manufacturing and testing sites are appropriately authorized and GMP compliant.
• Confirm completeness and compliance of batch documentation, investigations, validations, and QC data prior to certification.
• Ensure appropriate qualification of starting materials, packaging materials, and suppliers.
• Maintain appropriate oversight of any delegated QP?related activities, retaining full accountability for certification decisions.
• Maintain up?to?date QP training and ensure ongoing regulatory and product knowledge.

Qualifications:

• Required:
• Bachelor’s degree in Pharmacy, Life Sciences Engineering, or a related discipline.
• Educational qualifications meeting EU QP eligibility requirements as defined in Directives 2001/83/EC and applicable national legislation.
• 5+ years of Quality experience in pharmaceutical manufacturing, clinical trial packaging and labeling, pharmaceutical distribution within a GxP environment.
• Strong working knowledge of EU GMP, Annex 13, Annex 16, GDP, and HPRA expectations.
• Experience managing quality systems, audits, deviations, CAPAs, and change control.
• Proven ability to work cross?functionally and manage multiple priorities.

Preferred:

• Prior experience in a clinical trial supply services organization.
• Experience serving as a named QP on an MIA IMP.
• Experience leading or developing other Quality professionals.

Position Summary:

The Production Associate will report into the Operations Supervisor and will be actively involved in developing, implementing, and enforcing policies that ensure the safety and efficiency of secondary packaging and labeling. The successful candidate will have experience in different types of label application (single panel, booklet, flag, etc.), application at multiple temperature ranges, including frozen, ultra frozen, and refrigerated, and management and data integrity of blinded production activities. The selected candidate will have a strong focus on client service, delivery, and reliability. This candidate should have at least one year of experience in GMP warehouse environment and secondary packaging and labeling, can quickly switch gears to handle a range of duties and is proficient with ERP platforms

Responsibilities:

• Participate in secondary packaging runs.
• Ensure packaging runs are completed to the highest quality.
• Work cross functionally with Procurement and other sites on label, carton stock, and bill of material ordering and inventory.
• Work cross functionally with Warehouse Operations team for resource allocation
• Report any staff issues or capacity conditions to Operations Supervisor or above.
• Update and maintain production calendar for assigned site.
• Perform transactions in 1Source postproduction.
• Work with PM on inventory inquiries as required.
• Develop and maintain cleaning schedule of all rooms.
• Ensure all health and safety guidelines are enforced and maintained.
• Constant focus on continuous improvement in the secondary packaging and labelling environment.
• Participate and provide updates on a regular basis of packaging runs, completion, and challenges.
• Participate in warehousing activities if there is lower volume in packaging and labelling.
• KPI tracking and reporting of packaging and labelling metrics as per Leadership and client specifications, where applicable.
• Other duties as assigned.

Qualifications:

• One year of experience in GMP warehouse environment
• One year of experience in Secondary Packaging and Labeling
• Experience in Good Documentation Practices preferred
• Experience in different types of label applications at multiple temperature ranges preferred

Must be willing to Package and Label in 2-8C and -20C conditions with appropriate Personal Protective Equipment (PPE)

Position Summary:

The QA Manager is the senior Quality representative at the West Deptford, NJ facility and is responsible for the effective implementation, maintenance, and continuous improvement of the Pharmaceutical Quality System (PQS) locally. This role provides quality oversight of GMP/GDP operations supporting packaging, labeling and distribution in support of clinical trials, ensuring compliance with US regulations, applicable state regulations, internal SOPs and customer expectations.

The role serves as the primary site Quality lead, supporting inspections, audits, supplier qualification, quality events management, and training, while partnering cross?functionally to embed a strong culture of quality and compliance. On-site Quality personnel will directly report to the QA Manager.

Responsibilities:

• Ensure ongoing compliance with applicable FDA regulations, cGMP, GDP, state regulations, and internal SOPs.
• Maintain and continuously improve the site Pharmaceutical Quality System (PQS).
• Act as Quality lead for the West Deptford facility, providing daily QA oversight of operations.
• Review and approve controlled documents such as SOPs and work instructions.
• Provide QA oversight for clinical trial related services, including receipt, storage, label printing, secondary packaging and labeling, and distribution of products used in clinical trials.
• Review and approve clinical packaging and labeling batch documentation.
• Provide QA oversight of activities such as temperature monitoring, sanitation, environmental controls, calibration, and preventive maintenance.
• Ensure GMP/GDP facilities, systems, and equipment maintain a qualified/validated state.
• Review, approve, and manage deviations, CAPAs, change controls, risk assessments, complaints, and investigations within the EQMS ensuring data integrity and timely closure.
• Lead or support root cause investigations and ensure timely, effective corrective and preventive actions.
• Support and execute product recalls in accordance with SOPs and legal/regulatory guidance when required.
• Host and support customer audits, regulatory inspections, and internal self?inspections.
• Ensure inspection readiness and timely, compliant responses to audit observations.
• Serve as a Quality point of contact for customers and regulatory authorities as needed.
• Qualify, assess, and monitor suppliers and service providers using a risk-based approach.
• Review and maintain Quality Agreements / Technical Agreements with suppliers and customers.
• Develop, deliver, and oversee GMP/GDP and SOP training programs and assess training effectiveness.
• Assess training effectiveness and identify ongoing training needs.
• Assist in recruiting, onboarding, coaching, and mentoring Quality team members.
• Promote a proactive quality culture across all functions and levels.
• Drive continuous improvement initiatives to enhance compliance, efficiency, and quality performance.
• Track, trend, and report quality metrics to senior management and support management review activities.
• Stay current with changes in US and global pharmaceutical regulations, guidance, and industry best practices.

Qualifications:

• Required:
• Bachelor’s degree in Pharmacy, Life Sciences Engineering, or a related discipline.
• 5+ years of Quality experience in pharmaceutical manufacturing, clinical trial packaging and labeling, pharmaceutical distribution within a GxP environment.
• Strong working knowledge of FDA regulations, cGMP, GDP, and US regulatory expectations.
• Experience managing quality systems, audits, deviations, CAPAs, and change control.
• Proven ability to work cross?functionally and manage multiple priorities.

Preferred:

• Prior experience in a clinical trial supply services organization.
• Experience leading or developing other Quality professionals.
• Exposure to global regulatory environments (e.g., EMA).

Position Summary:

The personnel may perform/aid with the day-to-day Warehouse activities in compliance with current GxPs Including performing Production runs and Label Printing. 

General Duties Include but not Limited to:

• Responsible for overall conduction of incoming and outgoing shipments in coordination with Logistics team
• Responsible for conditioning temperature-controlled shippers
• Responsible to ensure that products are received and stored according to their labelled temperature requirements
• Responsible for dispatching and prioritizing shipping schedules appropriately
• Responsible for ensuring that the GxP operations are performed under clean, sanitary, and orderly conditions
• Responsible for conducting and documenting required Warehouse checks (e.g. temperature, sanitation, etc.)
• Responsible for physical inventory counts and reporting inventory discrepancies to the Manager and QA
• Responsible for filing Operations related documentation and ensuring their accessibility for audits.
• Responsible for Label Printing. 
• 10. Ensuring secondary packaging and labelling services are conducted in a timely fashion
• Responsible for removing any expired and damaged goods from saleable inventory following relevant SOPs.
• Responsible for assisting Manager in leading 3PL projects.
• Responsible for notifying QA of any issues that may impact the quality and integrity of the products.
• Responsible for informing QA of any facility, procedural, storage, transport changes prior to implementation, and initiating Change Requests for QA approval.
• Responsible for initiating Deviations/CAPAs for QA approval.
• Responsible for assisting in executing recalls according to legal agents’ instructions.

Qualifications:

• Leaving cert or Equivalent 
• Excellent written and spoken English
• Good Numerical skills.
• Counterbalance forklift or Power Pallet license preferable but not essential .
• Ability to work under own initiative