Quality Assurance Manager

Quality Assurance Manager at RxSource Quality Assurance Manager at RxSource in Thorofare, New Jersey Posted in about 22 hours ago.

Type:

full-time

Job Description:

Company Overview:

At RxSource, our passion is to improve the lives of patients. As a global provider of clinical trial supply services, we support pharmaceutical and biotech partners for clinical trial supply projects by delivering industry leading timelines with our flexible capacity planning and a dedication to achieve the extraordinary. With operations in Canada, the USA, and Ireland, our portfolio of services include; sourcing of commercial products (comparator, co-medications, rescue medications, ancillaries), packaging, labelling and distribution of clinical trial supplies within temperature-controlled conditions through our facilities. Our team and culture are our greatest strengths-driven by our core values, a can?do attitude, and deep expertise. This is what sets us apart. When you partner with us, your trial is our passion.

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).