Quality Assurance, CMC (Manager)

Position: Quality Assurance CMC (Manager)

Position Summary

Karuna is seeking an experienced and motivated individual to join our Quality Assurance team as Manager, CMC Quality Assurance to support drug development from Phase 1 to commercialization. Reporting to the Associate Director, Quality Assurance CMC, this position is responsible for managing, reviewing, and approving quality documents from Contract Manufacturing Organizations and Contract Testing Laboratories for manufacturing, testing, validation, and disposition of clinical and commercial products for human use. This position will work closely with CMC, regulatory affairs, and other functional teams.

Responsibilities

• Ensures compliance to cGMP policies and procedures for documentation resulting from manufacturing operations of clinical and commercial small molecule API and drug product.
• Provides Quality oversight of protocols, starting material and finished product specifications, API and DP manufacturing, analytical and stability reports.
• Ensures corporate readiness towards regulatory CMC inspections.
• Ensures data integrity in GMP documentation from manufacturing, analytical and stability studies.
• Performs disposition activities for manufactured products in support of Commercial/Clinical Product, including Master Batch Record review, Executed Batch Record review, resolution of comments/issues and Certificate of Analysis review.
• Performs assessments and QA review of Change Controls, deviations, root cause analysis, and product impact assessments and investigations, including OOS investigations, for commercial and clinical products.
• Reviews product release and stability data.
• Supports other QA operation or compliance activities as needed.

Required Qualifications

• BS/BA in Chemistry, Biology, Pharmaceutics, or other science related field.
• Minimum six years of experience within the pharmaceutical industry and in a Quality Assurance role.
• Knowledge of FDA, EU, ICH requirements for GMP and related areas, e.g., 21 CFR 211, Part 11 / Annex 11, ICH Q7 etc.
• Experience in reviewing Specifications, MBRs, EBRs, stability protocols, method validation protocols and reports etc.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
• Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
• Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues.
• Broad experience in an emerging, publicly traded company environment is a plus.

The successful candidate will also embody our values:

Our purpose is to create value for those we have the privilege to serve:

• We take pride in our work
• We keep our promises and deliver
• We are driven to meaningfully innovate
• We succeed through inclusion and teamwork

Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

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