Associate Director, Quality Assurance

Overview

Associate Director, Quality Assurance at Akebia Therapeutics – Cambridge, MA. This is a full-time, regular role.

Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance

Responsibilities

• Ownership of Standard Operating Procedures (SOPs) related to Quality Product Complaints and interfacing programs for clinical and commercial complaints. Ensure that all SOPs are compliant with FDA’s current Good Manufacturing Practices (cGMP).
• Management and oversight of all commercial Quality product complaints, including investigation, follow-up, review and approval of product complaints and associated manufacturing investigations to ensure completeness and accuracy.
• Troubleshoot and escalate product complaints, as appropriate.
• Support processes involving defective products and participation in the filing of Field Alert Reports and execution of recalls as required by the company and FDA or other regulatory agencies as necessary.
• Maintain systems to track and trend key quality indicators; ensure monthly KPIs are issued on time and deficiencies are addressed promptly.
• Collaborate cross-functionally with internal customers, partners and CMOs to accomplish company objectives and team goals, including product complaint and adverse event investigations, FARs, and recalls.
• Monitor and report on new compliance initiatives and regulations from Regulatory authorities related to product complaints, deviations, change controls and/or CAPAs, as applicable.
• Monitor industry and Akebia inspection trends, new/revised regulations regarding product quality complaints, deviations, change controls, CAPAs, trending, and/or guidance for impact to the Quality organization.
• Represent QA on teams and related working groups and Quality governance forums, as appropriate; investigate and facilitates reporting of critical compliance issues.
• Support CAPA plan development and perform effectiveness checks of CAPAs as required.
• Support regulatory agency inspections, as needed.
• Foster a commitment to quality and a culture of quality within the organization.
• Support the Supplier Quality and inspection programs with respect to compliance input and identified trends.
• Provide Quality & compliance input related to new and often complex Quality/QMS processes.
• Ensure adherence to departmental SOPs.
• Lead intra- or interdepartmental teams of an operational nature (e.g., preparing Akebia for minor changes in regulations, continuous improvement initiatives).
• Review and approve deviations, investigations and findings, verifying conclusions drawn are reflected in approved CAPAs.
• Support the preparation of annual product reviews (APRs) and relevant trending metrics; contribute to the Akebia CPV program with input and trending metrics.

Qualifications

• Basic Qualifications: Bachelor’s degree in a scientific discipline or Engineering is required; an advanced degree is strongly preferred.
• 8+ years of experience in the pharmaceutical industry.
• Excellent written and oral communication skills, with the ability to draft, review, and approve technical reports.

Preferred Qualifications

• MS degree preferred.
• Audit and compliance experience; recognized as an expert resource on GXP compliance topics.
• Strong verbal and written communication and interpersonal skills.
• Proficient in Microsoft Office; experience with audit management/CAPA programs strongly preferred.
• Excellent organization skills and project management.
• Able to work effectively as part of a team or independently.
• Ability to travel up to approximately 25%.

Compensation

Targeted Base: $156,859 - $193,768. Base pay may depend on qualifications, skills, competencies, and experience and may fall outside the range shown. Base pay is one component of the total rewards package, which also includes bonus/incentive programs (if applicable), equity, and standard benefits (health care, vision, dental, retirement, PTO, etc.).

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