Compliance Specialist Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related discipline.
• 4+ years of pharmaceutical or GMP manufacturing experience.
• Experience with investigations, CAPAs, audits, and quality systems.
• Strong knowledge of cGMPs, compliance requirements, and safety programs.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Excellent verbal and written communication skills, including presentation skills.
• Demonstrated ability to manage projects and priorities to meet deliverables and timelines.
• Strong attention to detail, flexibility, and awareness of production and associated quality issues.
• Ability to work in a dynamic environment with rapidly changing needs.
• Ability to work across functions and sites, and with all levels of staff and management.

Nice To Haves

• Experience in drug product manufacture/testing.
• Oral drug product knowledge and experience.
• Knowledge of R&D or clinical supply areas and processes.
• Experience with manufacturing investigations and CAPAs.
• System knowledge of Veeva and SAP.

Responsibilities

• Champion a strong safety culture and ensure adherence to site, corporate, and regulatory safety requirements within Building 880.
• Build collaborative working relationships and effective communication with stakeholders across manufacturing, process engineering, analytical testing, quality assurance, regulatory, and related functions.
• Support safety observations, incident investigations, risk assessments, and corrective action implementation.
• Serve as the compliance subject matter expert for GMP manufacturing operations within Building 880 Non-Sterile Operations.
• Support implementation of the clinical supply QMS through participation as a topic team member and/or subject matter expert.
• Lead and support deviations, investigations, CAPAs, change controls, and risk assessments for Building 880.
• Drive sustained audit and inspection readiness through routine compliance monitoring and self-assessments.
• Partner with Quality, EHS, Engineering, and Operations to resolve compliance risks and prevent recurrence.
• Support facility compliance, audit readiness, and continuous improvement through drafting, reviewing, and advising on deviations, investigations, change records, and related quality documents.
• Oversee SOP lifecycle management and procedural compliance within the facility.
• Develop or update SOPs to ensure current practices are accurately reflected and support SOP and quality-related document approval as appropriate.
• Monitor training and qualification status to ensure workforce readiness and compliance.
• Support implementation of standardized work and best practices across non-sterile operations.
• Analyze safety and quality metrics to identify trends and improvement opportunities.
• Apply Lean, MPS, and root cause problem-solving tools to improve operational performance and compliance outcomes.
• Promote right-first-time execution and sustainable compliance practices.
• Lead by example and foster a Safety First and Quality Always culture.
• Drive accountability, continuous improvement, and compliance excellence across Building 880 Non-Sterile Operations.
• Operate as a trusted partner and technical resource to the Associate Director and cross-functional stakeholders.
• Demonstrate sound judgment, strong ownership, and a proactive approach to issue prevention and resolution.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days
• annual bonus
• long-term incentive