- 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.
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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.
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