Executive Director, CMO Quality
Responsible for the organizational and programmatic elements of the company Quality Assurance program and quality system that apply to CMO (Contract Manufacturing Organization) partnerships.
This responsibility includes, but is not limited to, the effective planning and execution of quality related workflows between the company and respective CMOs, throughout the product life cycle (e.g.
development, regulatory submissions, validation, release, launch, distribution, maintained commercial support).
Essential Functions *Confirms applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of CMO operations, processes and products.
This may be in collaboration with the company and CMO quality I compliance resources.
*Develops, implements, and monitors progress against the the company Strategic Quality Plan, as relates CMO quality objectives, projects and goals.
*Provides update and recommendation to the company Quality Council, and senior management staff, with regard to the quality?? related status of such objectives, projects and goals.
*Participates in related (potential) field action I recall evaluations and decisions with senior Quality management.
*Represents company as the primary Quality Assurance liaison with CMOs relative to ongoing regulatory inspection activities, and subsequent response and action plan implementation.
*Serves as primary Quality Assurance contact and reviewer for circumstances involving OOS, deviation, non-conformance - and related impact assessment and action plan.
*Assures CMO quality agreements are in place prior to commercialization of product.
*Assures that all quality related laboratories (both within company as well as those that perform contract testing for the company), in association with CMO product manufacture, operate in an efficient and effective manner - as per respective supply and quality agreements.
Provides quality related subject matter expert (SME) support for proposed and existing CMO relationships, relative to new or amended products, processes, technologies, etc.
,- in regards to assuring integrity of related product quality, regulatory compliance and manufacturability.
Recommend actions from a quality perspective that result in cost reduction, efficiencies or increased profitability to the company.
This may include, but is not limited to, the quality support of product tech transfers from CMOs to our manufacturing sites, in close collaboration with the Technical Services function.
Responsible for recommending related budget and resource critical for CMO quality programming.
Basic Qualifications Bachelor's degree is required; A minimum of 7 years of Quality management experience related to the pharmaceutical manufacture, specializing in sterile dosage forms; A minimum of 7 years demonstrated pharmaceutical manufacturing operations experience with high and low volume businesses.
Preferred Qualifications Advanced degree in the life sciences preferred; In-depth knowledge and understanding of pharmaceutical industry laws, regulations and FDA/cGMP and International regulatory / ICH guidelines; Demonstrated ability to be proactive, exercise independent judgment and work effectively on cross-functional teams with all levels of management and other company personnel; Strong leadership and interpersonal skills, sound judgement, strong analytical skills, and excellent written and verbal communication skills. Category: Executive , Keywords: Chief Executive Officer (CEO)
This responsibility includes, but is not limited to, the effective planning and execution of quality related workflows between the company and respective CMOs, throughout the product life cycle (e.g.
development, regulatory submissions, validation, release, launch, distribution, maintained commercial support).
Essential Functions *Confirms applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of CMO operations, processes and products.
This may be in collaboration with the company and CMO quality I compliance resources.
*Develops, implements, and monitors progress against the the company Strategic Quality Plan, as relates CMO quality objectives, projects and goals.
*Provides update and recommendation to the company Quality Council, and senior management staff, with regard to the quality?? related status of such objectives, projects and goals.
*Participates in related (potential) field action I recall evaluations and decisions with senior Quality management.
*Represents company as the primary Quality Assurance liaison with CMOs relative to ongoing regulatory inspection activities, and subsequent response and action plan implementation.
*Serves as primary Quality Assurance contact and reviewer for circumstances involving OOS, deviation, non-conformance - and related impact assessment and action plan.
*Assures CMO quality agreements are in place prior to commercialization of product.
*Assures that all quality related laboratories (both within company as well as those that perform contract testing for the company), in association with CMO product manufacture, operate in an efficient and effective manner - as per respective supply and quality agreements.
Provides quality related subject matter expert (SME) support for proposed and existing CMO relationships, relative to new or amended products, processes, technologies, etc.
,- in regards to assuring integrity of related product quality, regulatory compliance and manufacturability.
Recommend actions from a quality perspective that result in cost reduction, efficiencies or increased profitability to the company.
This may include, but is not limited to, the quality support of product tech transfers from CMOs to our manufacturing sites, in close collaboration with the Technical Services function.
Responsible for recommending related budget and resource critical for CMO quality programming.
Basic Qualifications Bachelor's degree is required; A minimum of 7 years of Quality management experience related to the pharmaceutical manufacture, specializing in sterile dosage forms; A minimum of 7 years demonstrated pharmaceutical manufacturing operations experience with high and low volume businesses.
Preferred Qualifications Advanced degree in the life sciences preferred; In-depth knowledge and understanding of pharmaceutical industry laws, regulations and FDA/cGMP and International regulatory / ICH guidelines; Demonstrated ability to be proactive, exercise independent judgment and work effectively on cross-functional teams with all levels of management and other company personnel; Strong leadership and interpersonal skills, sound judgement, strong analytical skills, and excellent written and verbal communication skills. Category: Executive , Keywords: Chief Executive Officer (CEO)