Sr Specialist Quality Compliance

What we expect of you

Preferred Qualificationsnice to have

• Bachelor’s Degree in Life Sciences or Engineering
• 7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems
• Experience leading or coordinating inspection and audit activities, including managing information requests, preparing subject matter experts, supporting interviews, and coordinating inspection responses.
• Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections
• Experience in auditing and/or defending processes, procedures and decisions during Health Authority inspections
• Strong working knowledge of cGMP requirements and quality systems commonly assessed during inspections, including deviations, CAPAs, change control, training, validation, document management, and data integrity.
• Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
• Demonstrated ability to identify compliance risks and readiness gaps, lead cross-functional remediation, and ensure actions are completed and sustained.
• Experience managing staff and/or leading cross-functional teams, projects and/or programs
• Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs)
• Previous exposure to bulk drug substance manufacturing and quality assurance processes
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach

• Partner across functions to maintain a continuous inspection-ready state for a multi-product GMP manufacturing operation.
• Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes.
• Coordinate cross-functional readiness plans for upcoming Health Authority inspections and major audits, including mock inspections, war-room preparation, document review, and interview readiness.
• Support inspection and audit strategy for new product introductions to ensure new processes, facilities, systems, documents, and personnel are inspection ready prior to implementation and filing-related activities.
• Ensure inspection-related commitments, actions, and deliverables are clearly assigned, tracked to completion, and escalated as needed.
• Facilitate cross-functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination.
• Support preparation and maintenance of core inspection readiness content, including site overviews, facility maps, product flow summaries, SME rosters, document inventories, and inspection support tools.
• Coordinate document management and retrieval processes to support efficient and controlled responses during inspections and audits.
• Monitor readiness of quality systems and operational processes that are commonly scrutinized during inspections, including deviations, CAPAs, change control, risk management, complaints, training, validations, document management, and data integrity controls.
• Identify gaps, risks, or weak points that may affect inspection outcomes and work with functional owners to drive timely remediation.
• Facilitate and manage monthly management review
• Support site self-assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends.
• Develop and sustain close working relationships with internal stakeholders and external business partners, to ensure aligned and effective audit and inspection support.
• Ensure lessons learned from prior inspections, audits, commitments, and industry enforcement actions are incorporated into site readiness activities.
• Track regulatory commitments and support timely follow-up to ensure inspection observations, actions, and commitments are completed and sustainable.
• Provide compliance support during inspections, including schedule management, room coordination, request tracking, communication support, and facilitation of cross-functional issue resolution.
• Support drafting, coordination, and review of inspection responses and related action plans, as applicable.
• Escalate significant quality, compliance, supply, and inspection readiness risks to site quality and senior leadership.
• Support continual improvement initiatives that strengthen site quality culture, inspection readiness capability, and execution discipline.

What you can expect of us

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.