QMM Auditor (Quality Management and Maturity)

Title: QMM Auditor (Quality Management and Maturity)

Location: Remote

Status: Full Time

Position Summary:

To assess an establishment's QMM, it will be necessary to hire an train assessors who will evaluate relevant documentation and complete the QMM assessment at specified locations. The QMM assessment is designed to appraise an establishment's quality culture mindset, behaviors, and commitment to adopting best practices to effectively meet the needs of patients and consumers. Trained assessors will engage directly with establishments, for up to 5 business days. The QMM assessment will cover five practice areas:

(1) management commitment to quality;

(2) business continuity;

(3) advanced pharmaceutical quality system;

(4) technical excellence; and

(5) employee engagement and empowerment.

Within each practice area, the assessors will explore key elements to better understand an establishment's QMM. Examples of elements covered under each practice area could include: management review and resource management (management commitment to quality practice area), supply planning and demand forecasting (business continuity practice area), data governance and process optimization (technical excellence practice area), effectiveness of the corrective action and preventive action process (advanced pharmaceutical quality system practice area), and rewards and recognition (employee engagement practice area). Each establishment's responses, executed practices, and behaviors will be assessed using a standardized assessment protocol and an objective rubric to help identify areas of strength and potential areas with opportunities for improvement.

The primary focus of this role is to assess the quality, management, and maturity of each site visited in an effort to improve drug production and reduce drug shortages.

Duties/Responsibilities:

• Collaborates with CDER/OPQ/OQS staff to perform QMM assessments to evaluate the maturity of an establishment's quality management practices. The assessments will include preparation in advance of the assessment, document review, interviews, site assessments, and evaluations of an establishment's maturity using a prototype assessment protocol and defined rubric.
• Refines the prototype assessment protocol and defined rubric based on lessons learned from the assessments performed and a comparison against current standards, guidance's, literature, and other similar tools being developed to assess maturity.
• Develops a training program for assessors on how to conduct effective assessments using the protocol and defined rubric.
• Contributes to the creation of SOPs and communication materials.

Minimum Requirements:

• Bachelor's degree in science, public health, or regulatory science
• 5+ years of experience with pharmaceutical manufacturing and auditing pharmaceutical manufacturing operations.
• 2+ years of experience with technical writing and editing.
• Familiar with current good manufacturing practices and assessing the effectiveness of quality systems.
• Experience working in pharmaceutical development or commercial manufacturing preferred.
• Experience applying Quality Risk Management (QRM) principles throughout the product lifecycle.
• Knowledgeable on effective strategies for providing oversight of outsourced activities and suppliers.

Preferred Qualifications:

• Experience with foreign and domestic travel for business purposes.
• Experience leading laboratory or pharmaceutical manufacturing audits.
• Extensive experience with technical writing and editing.
• Prior experience conducting quality management and maturity assessments.
• One or more of the following: Certified Quality Engineer (CQE), (Lean) Six Sigma Green Belt, Certified Quality Auditor (CQA), CMMI Certification

Work Environment:

• Remote, Desk Based

Physical Demands:

• Lift 25 lbs.
• Mobility: site visits may require you to stand or walk for an extended period of time.

Apply online at our website: https://kikiktagruk.applicantpool.com/.

Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status, or any other legal protected status. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here. Successful candidate must pass, comply, and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.