Careers

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 successful candidate will have experience in pharmaceutical industry in both Logistics and Operations that will apply previous knowledge to coordinate Logistics and Operations initiatives by maintaining relationships with logistics service providers and customers, ensure shipments are done at a competitive cost and expand RxSource’s global presence. This position requires collaboration with the Customer Service, Business Development, Operations, QA and the Senior Management Team. The ideal candidate will be comfortable working within sensitive timelines and departmental guidelines.

This is a pivotal role that requires the candidate to have a proven Logistics and Operations experience, strong communication and analytical skills, and computer literacy to fulfill RxSource’s vision, mission and values. 

Responsibilities: 

• Responsible for overall logistics coordination and documentation control for including incoming and outgoing shipments.
• Preparing AWB and shipping documents (that includes customs documents like invoice).
• Liaising with clients, couriers and other operational departments regarding the shipping instructions.
• Dispatching and prioritizing shipping schedules appropriately.
• Assisting the clients to address and resolve any issues with the shipment. (e.g. delayed shipments).
• Assist in mitigating risk and in resolving any issues with shipments (e.g. delayed shipments).
• Maintaining distribution records.
• Documenting and informing QA team of any issues that may impact the quality and integrity of the products.
• Obtaining quotes from various logistics service providers and provide it to the respective departments.
• Maintaining customer shipment instructions log and update as needed.
• Collecting courier metrics.
• Assisting with regular business relationship meetings.
• Updating RTSM/IRT dispatch information. 

Qualifications:

• Post?secondary education in Supply Chain Management, Logistics, Business Administration, Operations Management, or a related field (required).
• 1-2 years of experience in Logistics and/or Operations, preferably within the pharmaceutical, biotech, or life sciences industry.
• Strong understanding of GxP, cold chain handling, and pharmaceutical distribution requirements (asset).
• Experience working with courier partners, freight forwarders, and global logistics service providers.
•  Strong analytical and problem?solving skills
• Ability to manage time?sensitive and high?priority shipments.
• Excellent communication skills, both written and verbal
• High level of computer literacy, including MS Office (Excel, Word, Outlook) and experience with RTSM/IRT systems (asset).
• Strong attention to detail and Ability to work independently and collaboratively in a fast?paced, deadline?driven environment.

Position Summary

Results-driven Business Development professional with a strong focus on driving comparator sourcing revenue growth, developing new client relationships, and expanding market presence within the U.S. and EU pharmaceutical and healthcare sectors.

Required: Network of existing relationships with clinical supply, procurement, sourcing, and operations leaders within pharmaceutical, biotechnology, and CRO organizations. Candidates must demonstrate a history of utilizing established industry contacts to consistently generate qualified opportunities and achieve sales growth objectives.

Strategy and Management

• Identify, prospect, and secure new comparator sourcing and clinical trial supply opportunities.
• Build relationships with pharmaceutical, biotech, and CRO stakeholders including:
• Manage the entire sales cycle from lead generation to contract execution.
• Collaborate with internal operations, contracts and project management teams to ensure successful customer outcomes.
• Present comparator sourcing solutions, supply chain strategies, and value-added services to prospective clients.
• Maintain accurate sales pipeline forecasting and CRM documentation.
• Represent the company at industry conferences, trade shows, and networking events.
• Monitor industry trends and emerging opportunities within the clinical trial supply market.

Qualifications 

• Bachelor’s degree in business, or a related field.
• Additional training or certifications in Sales, Business Development, Pharmaceutical Services, or Contract Management are considered an asset.
• Strong client relationship management and business development skills.
• Experience negotiating contracts, pricing, and service agreements.
• Proven ability to collaborate with cross-functional teams.
• Strong communication, stakeholder management, and presentation skills.
• Ability to identify growth opportunities and drive profitability.
• Experience with process improvement and operational efficiency initiatives.
• Results-oriented with strong analytical and reporting capabilities.
• Customer-focused with a commitment to delivering successful outcomes.

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