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posted_at: 8 days agoschedule_type: Full-time
Overview
Based in Chicago, the Vice President of Quality is a key leadership role responsible for the strategy, direction, and execution of all aspects of Quality initiatives, Quality Control, and training programs within Xeris. The position will collaborate across all functions and external stakeholders in the execution of quality programs to ensure compliance in GxP-related activities (GLP... GMP, and GCP) and provide expertise in Drug Substance,
Overview
Based in Chicago, the Vice President of Quality is a key leadership role responsible for the strategy, direction, and execution of all aspects of Quality initiatives, Quality Control, and training programs within Xeris. The position will collaborate across all functions and external stakeholders in the execution of quality programs to ensure compliance in GxP-related activities (GLP... GMP, and GCP) and provide expertise in Drug Substance, Drug Product, Device analytical testing, release and stability of products. The ideal candidate has successful experience scaling up a quality organization and thrives in a fast-paced, evolving environment where they can be both strategic and operational.
Responsibilities
• Establish and promote a culture of quality throughout the organization in partnership with the executive team
• Provide leadership, direction and coordination across functional areas to drive integrated delivery of quality assurance programs
• Oversee Quality Control operations with Suppliers and Contract sites (CDMO, CMO, Laboratories), including vendor selection, relationship management, auditing, Quality Agreements, order/SOW management, material/method, etc.
• Oversee design, development and execution of employee quality training programs
• Provide global quality systems and processes that ensure operational efficiency and compliance
• Ensure regulatory inspection preparedness for both internal facilities and external partners
• Identify potential areas of compliance vulnerability and risk; lead development and implementation of corrective action plans for resolution to ensure conformity with regulatory commitments and regulations
• Contribute to the preparation of regulatory submissions and represent Xeris in interactions with FDA, EMA and other regulatory agencies
• Author analytical sections for Drug Substance and Drug Product sections of the eCDT for INDs, NDAs, and other health authority submissions.
• Serve as the QA batch review and release authority for the company's clinical and commercial products
• Oversee the Mid/late Stage clinical and commercial stability programs, manage SLIM database, recommend appropriate product shelf-life and investigate OOT/OOS results.
• Provide periodic updates to the executive team and Board of Directors on the state of quality assurance
• Drive goal setting, budget development and strategy for quality assurance in alignment with corporate goals
• Manage the professional development of direct reports through deployment of a proactive talent management strategy, active coaching and mentoring
Qualifications
• Bachelor's degree in life sciences, biotechnology, chemistry, or relevant field, advanced Master s/PhD degree preferred
• Minimum of 15 years of progressive experience in US FDA-regulated pharmaceutical device development and manufacturing of combination products. Global experience preferred
• Experience with GXP auditing/compliance
• Extensive GMP experience preferred
• Seasoned veteran in Quality Controls and Validation Operations
• Deep understanding of Quality Systems in support of investigations and quality events
• Ability to effectively work with R&D scientists, CMC engineers, Regulatory
• Demonstrated successful leadership and team building skills as well as the ability to perform effectively in a dynamic and evolving environment
• Previous experience working in a virtual or small company environment preferred
• Superior knowledge of pharmaceutical Quality Assurance principles, concepts, industry practices and standards including combination products, ISO standards and ICH guidelines
• Proven ability to interact with stakeholders to define objectives and priorities within the scope of the project/program/initiative
• Familiarity with electronic quality management systems
• Experience with regulatory agency interactions, including FDA and EMA
• Competencies: Strong Business Acumen, Executive Presence, Strategic Leadership, Innovative, Skilled Communicator, Team Developer, Excellent Judgement, Complex Problem Solving, Highly Organized, Detail-Oriented
• Ability to travel up to 50% both domestically and internationally
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors Show more details...
Based in Chicago, the Vice President of Quality is a key leadership role responsible for the strategy, direction, and execution of all aspects of Quality initiatives, Quality Control, and training programs within Xeris. The position will collaborate across all functions and external stakeholders in the execution of quality programs to ensure compliance in GxP-related activities (GLP... GMP, and GCP) and provide expertise in Drug Substance, Drug Product, Device analytical testing, release and stability of products. The ideal candidate has successful experience scaling up a quality organization and thrives in a fast-paced, evolving environment where they can be both strategic and operational.
Responsibilities
• Establish and promote a culture of quality throughout the organization in partnership with the executive team
• Provide leadership, direction and coordination across functional areas to drive integrated delivery of quality assurance programs
• Oversee Quality Control operations with Suppliers and Contract sites (CDMO, CMO, Laboratories), including vendor selection, relationship management, auditing, Quality Agreements, order/SOW management, material/method, etc.
• Oversee design, development and execution of employee quality training programs
• Provide global quality systems and processes that ensure operational efficiency and compliance
• Ensure regulatory inspection preparedness for both internal facilities and external partners
• Identify potential areas of compliance vulnerability and risk; lead development and implementation of corrective action plans for resolution to ensure conformity with regulatory commitments and regulations
• Contribute to the preparation of regulatory submissions and represent Xeris in interactions with FDA, EMA and other regulatory agencies
• Author analytical sections for Drug Substance and Drug Product sections of the eCDT for INDs, NDAs, and other health authority submissions.
• Serve as the QA batch review and release authority for the company's clinical and commercial products
• Oversee the Mid/late Stage clinical and commercial stability programs, manage SLIM database, recommend appropriate product shelf-life and investigate OOT/OOS results.
• Provide periodic updates to the executive team and Board of Directors on the state of quality assurance
• Drive goal setting, budget development and strategy for quality assurance in alignment with corporate goals
• Manage the professional development of direct reports through deployment of a proactive talent management strategy, active coaching and mentoring
Qualifications
• Bachelor's degree in life sciences, biotechnology, chemistry, or relevant field, advanced Master s/PhD degree preferred
• Minimum of 15 years of progressive experience in US FDA-regulated pharmaceutical device development and manufacturing of combination products. Global experience preferred
• Experience with GXP auditing/compliance
• Extensive GMP experience preferred
• Seasoned veteran in Quality Controls and Validation Operations
• Deep understanding of Quality Systems in support of investigations and quality events
• Ability to effectively work with R&D scientists, CMC engineers, Regulatory
• Demonstrated successful leadership and team building skills as well as the ability to perform effectively in a dynamic and evolving environment
• Previous experience working in a virtual or small company environment preferred
• Superior knowledge of pharmaceutical Quality Assurance principles, concepts, industry practices and standards including combination products, ISO standards and ICH guidelines
• Proven ability to interact with stakeholders to define objectives and priorities within the scope of the project/program/initiative
• Familiarity with electronic quality management systems
• Experience with regulatory agency interactions, including FDA and EMA
• Competencies: Strong Business Acumen, Executive Presence, Strategic Leadership, Innovative, Skilled Communicator, Team Developer, Excellent Judgement, Complex Problem Solving, Highly Organized, Detail-Oriented
• Ability to travel up to 50% both domestically and internationally
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors Show more details...
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