Senior Specialist, Quality Assurance (Hybrid

Senior Specialist, Quality Assurance BDQR

The Biologics Development Quality group in Rahway (BDQR) within Global Development Quality is responsible for technical, operational and quality oversight of a growing and fast-moving large molecule pipeline. BDQR is specifically focused on quality oversight for large molecule drug substance process & analytical development, GMP clinical manufacturing, and the testing & release of clinical supplies.

The Senior Specialist, Quality Assurance BDQR is responsible for providing Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring compliance with cGMPs, applicable worldwide regulations, and our Company requirements for supported area(s). The Senior Specialist applies a strong Quality mindset, partners with stakeholders, and supports compliant execution and decision-making across routine operations and quality events.

Primary Responsibilities include but are not limited to:

• Provide Quality oversight and execute GMP/GxP quality assurance activities supporting manufacturing and testing operations, including material and batch documentation review and batch disposition.
• Provide Quality oversight of an evolving biologics clinical space by identifying potential compliance risks, escalating issues as appropriate, and helping ensure compliant execution in fast-paced operational areas.
• Support operational readiness by partnering cross-functionally to enable compliant start-up and execution of GMP activities.
• Apply a quality-by-design mindset by supporting appropriate use of quality systems, procedures, and documentation controls through planning, execution, and routine operations.
• Build and maintain effective partnerships with key stakeholders to provide Quality guidance, support timely decision-making, and contribute to oversight of quality events, including deviations, change controls, CAPA, and audit support.
• Contribute to a culture of compliance and continuous improvement by supporting training expectations, audit readiness, and quality performance monitoring/metrics.
• Remain informed of current GMP requirements and industry trends in the large molecule, analytical, and manufacturing areas to applicable worldwide regulations and industry standards. Maintain a proficient level of knowledge related to areas of technical expertise.
• Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensuring periodic updates, as appropriate.
• Manage the review and/or approval of analytical and process GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.
• Act as Quality representative for internal or external manufacturing and testing of programs. Duties include compliance oversight of program-related activities, batch record review and approval, deviation and/or out-of-specification approval.
• Represent the department or area on project teams establishing quality standards, policies or expectations within our Company.
• Manage the clinical release or re-evaluation dating to ensure conformance to appropriate worldwide regulatory requirements.
• Provide quality oversight deliverables for large molecule drug substance analytical development and testing & release of clinical material.
• Review and approve analytical and manufacturing documents.
• Contribute to establishment and sustainability of a safety first, compliance always culture.

Education Minimum Requirement:

Bachelor's degree in science, engineering, or related discipline

Required Experience, Knowledge, and

Skills:

• Minimum of 5 years of experience in Pharmaceutical / Biotechnology industry role(s) with a BS, or 3+ years with an advanced degree.
• Experience in Biologics Quality, Biologics Manufacturing, and/or related functions at pilot and/or commercial scale.
• Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
• Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment (i.e., apply the GMP Continuum).
• Demonstrated ability to manage projects and priorities to meet deliverables and timelines.
• Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Preferred

Experience and Skills:

• Experience with quality risk management.
• Experience supporting cross-functional teams and contributing to problem-solving situations.
• Strong knowledge of biologics manufacturing processes, biologics analytical method validation and testing, and regulatory requirements.
• Technical knowledge or proficiency in one or more elements of: GMP cleanroom facilities, electronic batch records, data integrity, SAP, automation, GMP operations in various product modalities or associated technologies.
• Ability to identify, assess, and support resolution of complex problems in a timely and efficient manner.
• Experience in…