Senior Vice President of Quality Management
2 weeks ago
POSITION TITLE:
Senior Vice President of Quality Management
DIVISION:
Regulatory Affairs
EMPLOYMENT TYPE:
Full-Time
HI-Bio, Inc. is a pioneering biotechnology firm located in South San Francisco, California.
Our collective mission is to revolutionize the treatment of patients suffering from severe immune-mediated disorders by creating innovative targeted therapies that deliver significant clinical benefits in a timely manner.
Our robust pipeline is developed through both in-licensing and original research. The team at HI-Bio comprises seasoned professionals from scientific and clinical drug development backgrounds. We are committed to establishing a leading position in the field of immunology. To achieve this, we are in search of exceptional talent to accompany us on our journey.The Senior Vice President of Quality Management is tasked with supervising and engaging in the phase-appropriate development, execution, and upkeep of quality management practices and systems as dictated by GCP, GMP, and GLP (GxP) regulations, ensuring adherence to internal policies, business goals, procedures, and external regulations and standards.
We are looking for a dynamic and experienced Quality Professional who can provide strategic insight and strong leadership capabilities while also adopting a hands-on approach to further enhance the Quality function at HI-Bio.
The Senior Vice President of Quality Management will hold comprehensive Quality responsibilities, including leading GMP, GCP, and GLP operations. This role will report to the Senior Vice President of Regulatory Affairs, Quality, and Pharmacovigilance.PRIMARY RESPONSIBILITIES:
Continuously develop and maintain a phase-appropriate Quality Management System (QMS) and oversee its administration.
Ensure quality and operational regulatory compliance; serve as a subject matter expert for quality investigations, documentation systems, training programs, and internal/external audits.
Collaborate with cross-functional teams to represent quality with external suppliers; maintain and implement suitable supplier qualification processes.Oversee the qualification process utilized in the selection and qualification of clinical, nonclinical, and manufacturing vendors/contractors.
Participate in the selection, qualification, and oversight of local quality consultants and Qualified Persons (QPs) in various regions where GXP contracted activities are required.
Manage clinical/pre-clinical program quality audit planning, execution, and resolution of issues.Schedule and lead regular Quality Management Reviews on compliance status, Quality Metrics, and Quality Standards for facilities, processes, procedures, and practices.
Provide quality oversight of GMP documentation, including master batch records, validation protocols, and QC test methods.Lead regulatory inspections and represent HI-Bio at supplier inspections, as necessary.
Address product complaints, changes, and deviations; lead or support investigations to resolve quality issues.
Oversee and implement GXP and SOP training programs; maintain a centralized system for GXP documents, including record control, archival, protection, and access.
Develop the Quality Assurance operating budget and monitor expenditures.Identify GXP and other key compliance requirements and provide leadership in promoting awareness and understanding of global regulatory compliance expectations.
Lead the Audit Program management process, including assessment of internal and external (outsourced) GXP operations.Collaborate with cross-functional and other internal project teams to effectively support process and quality enhancement initiatives.
In partnership with the CMC group, manage the approval process for raw materials, packaging materials, intermediate and finished products according to the appropriate regulations and site procedures.
In collaboration with the CMC group, provide quality oversight into the testing program for materials and products, including stability monitoring programs.
Work with senior management to ensure that best practices and proper training are adopted, including compliance with all quality policies, quality improvement initiatives, and ensuring appropriate quality systems are implemented and maintained.
Ensure quality data integrity and that CDMO manufactured products meet Health Authority regulations and company standards.EDUCATION AND EXPERIENCE:
Bachelor's degree or advanced degree (preferred) in a scientific discipline
Minimum of 15+ years of quality experience in a biotech/pharma setting, with at least 5-7 years as the head of quality
Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and guidance documents
Experience in leading and managing regulatory inspections
Strong working knowledge of GMP/GCP principles
Hands-on experience with implementing and managing Quality/Compliance systems and processes
Ability to thrive in a dynamic, start-up environment with aggressive timelines and multiple deliverables.
Possess professional communication skills, strong independent time management skills, and the ability to manage multiple projects concurrently in an organized manner.
A proven track record of partnering and managing quality business objectives with CMO/CDMOsExperience in selecting and overseeing Qualified Persons (QPs) for product quality objectives and product release per geographical requirements
Able to travel domestically and internationally
HI-BIO RECRUITING:
HI-Bio, Inc. is an equal opportunity employer.
We value diversity and do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
We are dedicated to fostering an inclusive environment for all employees.HI-Bio Inc. does not accept unsolicited resumes from any agency that we have not directly engaged for a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to HI-Bio, Inc. from recruiters do not establish any type of relationship between the recruiter and/or recruiting agency and HI-Bio, Inc. and do not obligate HI-Bio, Inc. to pay fees should we hire from those resumes.
#J-18808-Ljbffr
-
Senior Vice President of Quality Management
2 weeks ago
South San Francisco, California, United States Hibio Full timePOSITION TITLE: Senior Vice President of Quality ManagementDEPARTMENT: Regulatory AffairsEMPLOYMENT TYPE: Full-TimeHI-Bio, Inc. is a pioneering biotechnology firm located in South San Francisco, California. Our mission is to revolutionize the treatment of patients suffering from severe immune-mediated disorders by developing innovative targeted therapies...
-
Senior Vice President of Quality Assurance
5 days ago
South San Francisco, California, United States Annexon Bioscience Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Vice President of Quality Assurance to join our team at Annexon Biosciences. As a key member of our leadership team, you will be responsible for overseeing and implementing our quality management systems, ensuring compliance with regulatory requirements, and driving continuous improvement...
-
Senior Vice President of Quality Assurance
2 weeks ago
South San Francisco, California, United States Annexon Bioscience Full timeWork Location Corporate Headquarters - Hybrid Position Overview Annexon Biosciences is in search of a Senior Vice President of Quality Assurance who will take charge of comprehensive Quality responsibilities, encompassing the leadership of GMP, GCP, and GLP operations. This role entails overseeing the formulation, execution, and upkeep of quality management...
-
Vice President of Quality Assurance
2 weeks ago
San Francisco, California, United States AmeriHealth Caritas Full timePosition Overview:AmeriHealth Caritas is in search of a dedicated and skilled Senior Vice President to oversee our Quality and Health Equity division. The successful candidate will possess over a decade of leadership experience in Managed Care Quality, focusing on quality enhancement strategies and achieving superior quality outcomes across a diverse range...
-
Senior Vice President of Clinical Operations
1 week ago
San Francisco, California, United States University of California Full timeSenior Vice President of Clinical OperationsDepartment: Office of the President - Adult ServicesEmployment Type: Full TimeJob SummaryThe University of California is in search of a Senior Vice President of Clinical Operations to spearhead the integration of essential clinical services across both inpatient and outpatient facilities. This includes oversight of...
-
San Francisco, California, United States Northeastern University Full timeAbout the OpportunityThe Office of External Affairs at Northeastern University is seeking a highly skilled and motivated individual to serve as the Executive Assistant to the Senior Vice President (SVP). This role will play a critical part in the management of high-priority projects and provide administrative support to the SVP.Key...
-
Senior Vice President of Operations
1 week ago
San Francisco, California, United States Compass Group USA Full timeSENIOR VICE PRESIDENT OF OPERATIONSJob Overview:The Senior Vice President of Operations is responsible for overseeing the efficiency and effectiveness of business operations within the organization. This role involves fostering strong relationships with clients, identifying opportunities for profit enhancement, and formulating strategic initiatives.Key...
-
Senior Vice President of Wastewater Engineering
2 weeks ago
San Francisco, California, United States WSP Full timeSenior Vice President of Wastewater Engineering OpportunityWe are seeking a skilled Senior Vice President of Wastewater Engineering to enhance our team at WSP. This position offers flexibility in location across various offices. If you are dedicated to addressing regional wastewater and water issues and thrive on managing intricate projects, this role is...
-
Senior Vice President
1 week ago
San Francisco, California, United States MERU Full timeAbout MERUWe are MERU, a team driven by values and focused on making a significant impact by transforming businesses. Our firm specializes in providing advisory services and data analytics support to middle-market enterprises, with annual revenues ranging from $50 million to $2 billion. Our clientele includes private equity firms, credit funds, investment...
-
Vice President of Operations
2 weeks ago
San Francisco, California, United States Truenorth Executive Search, Inc. Full timeVice President of Operations – Equipment Rental & Distribution ServicesTruenorth Executive Search, Inc. is in search of a Vice President of Operations for a prominent, multi-site equipment rental and distribution services organization.This esteemed client has established itself as a leader in the industry and is poised for further growth and expansion into...
-
Senior Vice President, Credit Solutions
2 weeks ago
San Francisco, California, United States HSBC Full timeAbout UsAt HSBC, our mission is to unlock a world of possibilities for our clients. We leverage our extensive expertise and diverse perspectives to create new opportunities for over 40 million customers globally. Our commitment is to connect people, ideas, and capital to foster progress and growth, ultimately contributing to a better world for our customers,...
-
Senior Vice President of Sales
2 weeks ago
San Francisco, California, United States ECG Resources Full timePosition OverviewECG Resources is seeking a Senior Vice President of Sales to enhance our Private Client division. This role will serve as the primary liaison for Ultra High Net Worth (UHNW) clients, delivering a comprehensive range of investment strategies alongside wealth management services. The focus will be on fostering and nurturing client...
-
Senior Vice President of Philanthropy
1 week ago
San Francisco, California, United States Aim High Full timePOSITION OVERVIEWThe Aim High organization is a transformative summer enrichment initiative designed for students entering grades 6 through 9, particularly those facing systemic challenges in California. Provided at no expense to participants and their families for up to four consecutive summers, Aim High empowers middle school students to enhance their...
-
San Francisco, California, United States The VET Recruiter ® Full timeSenior Vice President of Hospital AdministrationWe are in search of a Senior Vice President of Hospital Administration to play a pivotal role in a dynamic team within the Veterinary sector. This position entails guiding hospital management teams, optimizing operational processes, and ensuring compliance with industry benchmarks across all facilities.The...
-
Senior Vice President of Wholesale Operations
2 weeks ago
San Francisco, California, United States Rothy's Full timeSenior Vice President of Wholesale OperationsRothy's, a leader in sustainable fashion, is on the lookout for a Senior Vice President of Wholesale Operations to spearhead our wholesale initiatives and enhance revenue streams. Our mission is to innovate by converting plastic waste into fashionable and functional products.Primary Responsibilities:Formulate and...
-
Senior Vice President of Operations
2 weeks ago
San Diego, California, United States Helix Electric Full timePosition Overview:The Senior Vice President of Operations is tasked with driving sustainable growth through the effective management of the initiation, development, and execution of new Commercial & Industrial (C&I), energy generation, and energy storage initiatives.Key Responsibilities:The Senior Vice President will oversee all operational functions,...
-
Executive Vice President
49 minutes ago
San Francisco, California, United States Goodall Brazier Full timeJob Summary:We are seeking an experienced Executive Vice President to join our team at Goodall Brazier. As a key member of our leadership team, you will play a critical role in driving our company's growth and success.About the Role:The Executive Vice President will be responsible for overseeing multiple projects across various markets, leveraging their...
-
Senior Vice President of Clinical Operations
2 weeks ago
San Francisco, California, United States UCSF Health Full timePosition OverviewThe Office of the President - Adult Services is seeking a Senior Vice President of Clinical Operations to spearhead the management of shared clinical services across various inpatient and outpatient facilities. This role encompasses oversight of essential services including Laboratory, Pathology, Imaging, and Rehabilitation Services.Key...
-
Senior Vice President of Quality Assurance
7 days ago
San Diego, California, United States Qualcomm Full timeCompany:Qualcomm Technologies, Inc.Job Area:Operations Group, Operations Group > QualityOverview:The Vice President of Quality and Reliability will report directly to a Senior Vice President at Qualcomm and will oversee a range of critical functions aimed at enhancing quality standards across the organization.Key Responsibilities:Lead the overall Quality...
-
San Francisco, California, United States SPAN Inc Full timeSenior Vice President of Residential Construction Sales & Business Development **Our Vision** SPAN is at the forefront of advancing renewable energy solutions for residential applications. The SPAN Smart Panel represents a significant innovation in home electrical systems, utilizing cutting-edge technology for enhanced metering, monitoring, and control. Our...
