Associate Manager, QA Compliance

MannKind Corporation•Danbury, CT

About The Position

At MannKind, we are dedicated to transforming chronic disease through innovative, patient-centric solutions designed to fit seamlessly into daily life. Our focus is on delivering therapies for people living with cardiometabolic and orphan lung diseases such as diabetes, pulmonary hypertension and fluid overload in heart and chronic kidney disease. At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company’s entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly. Our Values serve as the foundation of MannKind’s culture. They define who we are, how we act, and guide our interactions every day—both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together.

Requirements

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.

Responsibilities

Planning, executing, and reporting on internal and supplier/third-party quality compliance audits.
Partnering with cross-functional teams to investigate compliance gaps, track audit findings, oversee root-cause analyses, and manage Corrective and Preventive Actions (CAPAs).
Supporting inspection readiness and regulatory agency interactions.
Supporting auditor qualification through documented on-the-job training that demonstrates competency in required audit steps, tasks, and activities.
Developing 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.
Supporting 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.
Contributing 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.
Maintaining the approved vendor list, which identifies vendors, contract organizations, and service providers deemed acceptable based on completed audits.
Assisting with quality agreements that define the parties’ agreed roles and responsibilities for ensuring the quality of a product or service.
Supporting 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.
Supporting supplier-related activities involving nonconforming materials, deviations, and CAPA.
Supporting 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.
Performing Quality Control (QC) reviews of documents prepared for regulatory submissions.
Complying with all company health, safety, and environmental guidelines.