Senior Specialist, Quality Assurance

Merck; New Jersey; Sur place; USD 120 000 - 165 000; Plein temps

Résumé du poste

Merck is seeking a Senior Specialist, Quality Assurance BDQR to provide quality oversight and technical support for analytical and process development activities supporting large molecule programs.

In this role you will partner with stakeholders to ensure compliant execution, review batch documentation, support CAPA and deviations, and contribute to audit readiness and quality performance metrics across GMP operations.

Qualifications

• BS in science, engineering, or related discipline.
• Minimum 5 years in Pharmaceutical/Biotech roles with BS; 3+ years with advanced degree.
• Experience in Biologics QA, manufacturing, and/or related functions at pilot or commercial scale.
• Strong knowledge of cGMP and health authority regulations.

Responsabilités

• Provide quality oversight and QA activities for manufacturing and testing, including batch disposition.
• Identify compliance risks in biologics clinical space and escalate as needed.
• Support cross-functional readiness for GMP start-up and execution.
• Apply quality-by-design through quality systems, procedures, and documentation controls.
• Maintain SOPs and oversight of SOPs across areas.

Connaissances

Quality Assurance

GxP Compliance

cGMP Knowledge

Project Management

Communication

Formation

Bachelor's degree

Outils

SAP

Electronic Batch Records

Automation

Description du poste

Job Description

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

• 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 facility start-up and GMP Operational Readiness or clinical supply areas and processes.

Required Skills

• Audits Compliance, CAPA Management, Deviation Management, GMP Auditing, Manufacturing Processes, Operational Compliance, Operational Quality, Quality Assurance Processes, Quality Assurance Systems, Quality Risk Management