- Job Summary:
- The Associate Manager, Quality Compliance Audits is responsible for planning, executing, and reporting on internal and supplier/third-party quality compliance audits. This role partners with cross-functional teams to investigate compliance gaps, track audit findings, oversee root-cause analyses, and manage Corrective and Preventive Actions (CAPAs). The position also supports inspection readiness and regulatory agency interactions.
Essential Duties:
- *Support auditor qualification through documented on-the-job training that demonstrates competency in required audit steps, tasks, and activities.
- *Develop knowledge of the vendor-selection process, including identifying, evaluating, and selecting external providers based on their quality, business, and technical ability to meet defined requirements.
- *Support the external audit program for vendors and contract facilities that directly or indirectly affect CGMP, ISO, or MDSAP processes, including drug products, delivery systems, and related packaging, to verify compliance with applicable requirements, regulations, and standards.
- *Contribute to the GCP/PV audit program by auditing clinical investigators, trial sites, CROs, vendors, and other entities that provide Good Clinical Practice (GCP) or Pharmacovigilance (PV) services to MannKind Corporation.
- *Maintain the approved vendor list, which identifies vendors, contract organizations, and service providers deemed acceptable based on completed audits.
- *Assist with quality agreements that define the parties' agreed roles and responsibilities for ensuring the quality of a product or service.
- *Support supplier change notifications for changes that suppliers or vendors report to MannKind and that, under the applicable Quality Agreement, do not require MannKind's prior approval.
- *Support supplier-related activities involving nonconforming materials, deviations, and CAPA.
- *Support the internal audit program that monitors compliance with internal quality systems, company procedures, and applicable regulations and standards across all CGMP-, ISO-, and MDSAP-regulated operations and areas.
- *Perform Quality Control (QC) reviews of documents prepared for regulatory submissions.
- *Comply with all company health, safety, and environmental guidelines.
Qualifications:
*BA/BS in a scientific discipline with 4-6 years of related experience, or an MS/MBA with 2-4 years of related experience; an equivalent combination of education, training, and experience may be considered.
*Four to six years of experience, preferably in the pharmaceutical industry or another regulated environment.
*Knowledge of GxP compliance requirements and ISO standards.
*Demonstrated hands-on experience conducting or supporting quality/compliance audits.
*Ability to think strategically and creatively, with strong communication and interpersonal skills.
*Knowledge of applicable regulations and cGMP procedures.
*Effective verbal, written, and cross-functional influencing skills.
*Ability to work independently and collaboratively as part of a team.
*Strong interpersonal and communication skills.
*Ability to travel (approx. 10%-25%) for onsite supplier or facility audits, depending on business needs.
References to regulatory requirements or compliance include all applicable regulations and standards, such as FDA requirements, ISO 13485, and European requirements.Pay Range: $84,000 - $126,000 per year
