Quality Assurance, CMC (Senior Manager - Associate Director)
Position:
Quality Assurance, CMC (Senior Manager - Associate Director)Position SummaryKaruna is seeking an experienced and motivated individual to join our CMC QA team to lead small molecule QA Operations in support of drug development from Phase 1 to commercialization.
The position is responsible for managing QA oversight of Contract Manufacturing and Contract Testing Organizations for production, validation, testing, and disposition of any commercial product as well as investigational drugs for use in clinical trials.
Reporting to the Director, Quality Assurance CMC, this individual will work closely with other functional areas and CMC teams.
ResponsibilitiesEnsures compliance to cGMP, policies and procedures for documentation resulting from manufacturing operations for clinical and commercial small molecule API and DP.
Provides quality oversight of CMO operations for API and DP, including the approval of protocols, product specifications, API and DP manufacturing documents and records, method validation protocols and reports, process validation plans and reports, and stability protocols and reports.
Performs batch disposition activities in support of commercial/clinical products, 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, product impact assessments and investigations, including OOS/OOT investigations, for commercial and clinical products.
Participates in and/or leads risk assessment for design, process and product FMEAs.
Supports other QA operations and/or compliance activities as needed.
Required QualificationsBS/BA in Chemistry, Biology, Pharmaceutics, or other science related field.
Minimum of 10 years of experience within the pharmaceutical industry and in GMP roles, including Quality Assurance.
Sound knowledge of FDA, EU, ICH, ISO requirements for GMP and related areas.
Knowledge of global GMP requirements governing oral and non-oral small molecule drug products and knowledge of small molecule drug product manufacturing practices.
Experience in managing and identifying continuous improvement opportunities for cGMP quality systems, including In Process Controls, RSM and Product Specifications, Validation, Product Disposition, MBR & EBR review, and Stability programs.
Experience with formal, documented risk assessments (e.
g.
, FMEA).
Experience in development and management of Quality Agreements is a plus.
21 CFR Part 11 / Annex 11 Computer System Validation is a plus.
Ability to travel approximately 15%.
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 ability to manage multiple projects, 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 workWe keep our promises and deliverWe are driven to meaningfully innovateWe succeed through inclusion and teamworkKaruna 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.
#LI-Hybrid.
Estimated Salary: $20 to $28 per hour based on qualifications.
Quality Assurance, CMC (Senior Manager - Associate Director)Position SummaryKaruna is seeking an experienced and motivated individual to join our CMC QA team to lead small molecule QA Operations in support of drug development from Phase 1 to commercialization.
The position is responsible for managing QA oversight of Contract Manufacturing and Contract Testing Organizations for production, validation, testing, and disposition of any commercial product as well as investigational drugs for use in clinical trials.
Reporting to the Director, Quality Assurance CMC, this individual will work closely with other functional areas and CMC teams.
ResponsibilitiesEnsures compliance to cGMP, policies and procedures for documentation resulting from manufacturing operations for clinical and commercial small molecule API and DP.
Provides quality oversight of CMO operations for API and DP, including the approval of protocols, product specifications, API and DP manufacturing documents and records, method validation protocols and reports, process validation plans and reports, and stability protocols and reports.
Performs batch disposition activities in support of commercial/clinical products, 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, product impact assessments and investigations, including OOS/OOT investigations, for commercial and clinical products.
Participates in and/or leads risk assessment for design, process and product FMEAs.
Supports other QA operations and/or compliance activities as needed.
Required QualificationsBS/BA in Chemistry, Biology, Pharmaceutics, or other science related field.
Minimum of 10 years of experience within the pharmaceutical industry and in GMP roles, including Quality Assurance.
Sound knowledge of FDA, EU, ICH, ISO requirements for GMP and related areas.
Knowledge of global GMP requirements governing oral and non-oral small molecule drug products and knowledge of small molecule drug product manufacturing practices.
Experience in managing and identifying continuous improvement opportunities for cGMP quality systems, including In Process Controls, RSM and Product Specifications, Validation, Product Disposition, MBR & EBR review, and Stability programs.
Experience with formal, documented risk assessments (e.
g.
, FMEA).
Experience in development and management of Quality Agreements is a plus.
21 CFR Part 11 / Annex 11 Computer System Validation is a plus.
Ability to travel approximately 15%.
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 ability to manage multiple projects, 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 workWe keep our promises and deliverWe are driven to meaningfully innovateWe succeed through inclusion and teamworkKaruna 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.
#LI-Hybrid.
Estimated Salary: $20 to $28 per hour based on qualifications.
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