Manufacturing Quality Compliance Specialist

The Manufacturing Quality Compliance Specialist is a recognized internal expert in quality assurance, responsible for ensuring product safety, efficacy, purity, and quality through compliance with cGMPs, regulations, and procedures. This role supports inspection readiness and collaborates with business owners to maintain compliance through regular review of processes, procedures, and policies.

Role Responsibilities

• Ensure ongoing compliance with cGMP, FDA regulations (21 CFR Parts 210 & 211), and internal quality standards across manufacturing operations.
• Lead timely, thorough investigations of deviations, OOS results, QIRs, and CAPAs; ensure effective root cause analysis and corrective actions.
• Review and author GMP documents, including SOPs, Master Batch Records, and work instructions, ensuring clarity and regulatory compliance.
• Provide on-the-floor support to proactively identify, address, and resolve compliance issues in real time.
• Support regulatory and internal audit readiness; serve as a compliance representative during inspections and audits.
• Monitor, analyze, and report key quality and compliance metrics (e.g., investigation cycle times, training completion, deviation trends).
• Deliver training on cGMP, GDP, and compliance topics to reinforce a culture of quality.
• Collaborate cross-functionally with QA, Operations, Engineering, and other departments to maintain compliance and drive improvements.
• Support risk assessments, change control evaluations, validation reviews, and impact assessments for process changes.
• Lead or support continuous improvement efforts using Lean, Six Sigma, or similar methodologies to improve quality and efficiency.
• Participate in or lead quality-focused projects, initiatives, and team-based problem solving.
• Support batch record review and product release activities as needed.
• Act as a subject matter expert for compliance matters and mentor junior team members or peers on best practices.
• Perform other related duties as required to support departmental goals, business needs, or cross-functional initiatives. This may include special projects, temporary assignments, or responsibilities outside the standard scope of the role.
  
  

Required Skills And Experience

• Bachelor’s degree in Science, Engineering, or a related technical field with 5+ years of relevant experience.
• Proficient in Microsoft Office (Word, Excel, etc.).
• Strong written and verbal communication skills, with the ability to effectively engage all levels of the organization, including senior leadership and regulatory agencies.
• Strong analytical, problem-solving, and decision-making skills.
• Effective, tactful communicator with strong interpersonal and leadership abilities.
• Able to manage multiple projects and adapt to shifting priorities.
• Self-driven, collaborative, and committed to values-based leadership aligned with Kindeva’s mission and culture.
  
  

California residents should review our Notice for California Employees and Applicants before applying.

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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