Senior Director, Quality

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

Ensure compliance with all applicable local and global drug regulations.
Oversee Quality CMC functions with oversight and authority over batch disposition manufacturing packaging labeling and testing activities to ensure product quality and timely release of materials and products.
Provide hands-on leadership to effectively facilitate quality functions related to batch disposition investigations process and analytical data review supply distribution and risk management.
Serve as a point of contact for complex or high-risk quality issues and decisions.
Identify and manage quality risks across the product life cycle recommend and support mitigation strategies.
Operate closely with ORIC technical operations team Contract Manufacturing Organizations (CMOs) contract testing laboratories and distribution sites to facilitate quality review of process/analytical data and reports ensuring technical rigor and phase appropriate compliance to support program decisions.
Work cross-functionally with Regulatory Affairs to ensure timely and accurate review of submissions.
Operates closely with clinical program teams and serves as an active participant in clinical development meetings ensuring continuous quality support.
Develop performance-based quality metrics and trend analyses to drive continuous improvement.
Perform and present Annual Product Reviews for late-stage programs.
Lead mentor and develop a high-performing Quality team effectively scaling the team to support clinical into commercial programs.
Serve as Chair or primary Quality member in various governance committees including ORICs Stability Review Board Material Review Board and Change Review Board
Represent ORIC Quality in CDMO meetings regulatory authority interactions strategic leadership meetings as needed.
Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies workflows and priorities in response to changing business needs technologies and stakeholder expectations.
Develop new functional late phase commercial ready SOPs Policies/Plans as necessary.

Qualifications :

Bachelors or Masters degree in Chemistry Biology or a related scientific discipline
15 years of relevant experience in Quality Assurance and/or Quality Control in the pharmaceutical industry.
7 years of prior senior leadership experience.
Deep hands-on knowledge in ICH GMP and regulatory guidance relevant to new drug development and commercialization. Experience with preparing for commercial stage operations and regulatory interactions preferred.
Experience over a broad set of Quality Assurance functions with extensive knowledge of industry best practices and trends.
Ability to understand business objectives and how they translate into quality priorities.
Demonstrated ability to develop a vision for Quality functions as it transitions through the phases of drug development to commercialization.
Demonstrated success in working with and managing CDMOs and external partners using succinct and thorough communication skills.
Demonstrated ability to work independently and efficiently in a collaborative fast-paced integrated multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work.
Demonstrated initiative ownership problem identification problem solving and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met.
Results driven collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks
Excellent verbal and written communication skills with the ability to build productive long-term team relationships at all levels of supplier organizations including with senior executives
Skilled at managing autonomous high-performing professionals who value flexibility while ensuring alignment collaboration and delivery of results.

Additional Information :

The anticipated salary range for candidates who will work on-site at our San Diego location is between $220000-$270000. The final wage offered to a successful candidate will be dependent on several factors that may include title type and length of experience within the role type and length of experience within the industry education geography and other job-related factors.

ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.

Remote Work :

Employment Type :

Full-time

Ensure compliance with all applicable local and global drug regulations.Oversee Quality CMC functions with oversight and authority over batch disposition manufacturing packaging labeling and testing activities to ensure product quality and timely release of materials and products.Provide hands-on le...

Ensure compliance with all applicable local and global drug regulations.
Oversee Quality CMC functions with oversight and authority over batch disposition manufacturing packaging labeling and testing activities to ensure product quality and timely release of materials and products.
Provide hands-on leadership to effectively facilitate quality functions related to batch disposition investigations process and analytical data review supply distribution and risk management.
Serve as a point of contact for complex or high-risk quality issues and decisions.
Identify and manage quality risks across the product life cycle recommend and support mitigation strategies.
Operate closely with ORIC technical operations team Contract Manufacturing Organizations (CMOs) contract testing laboratories and distribution sites to facilitate quality review of process/analytical data and reports ensuring technical rigor and phase appropriate compliance to support program decisions.
Work cross-functionally with Regulatory Affairs to ensure timely and accurate review of submissions.
Operates closely with clinical program teams and serves as an active participant in clinical development meetings ensuring continuous quality support.
Develop performance-based quality metrics and trend analyses to drive continuous improvement.
Perform and present Annual Product Reviews for late-stage programs.
Lead mentor and develop a high-performing Quality team effectively scaling the team to support clinical into commercial programs.
Serve as Chair or primary Quality member in various governance committees including ORICs Stability Review Board Material Review Board and Change Review Board
Represent ORIC Quality in CDMO meetings regulatory authority interactions strategic leadership meetings as needed.
Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies workflows and priorities in response to changing business needs technologies and stakeholder expectations.
Develop new functional late phase commercial ready SOPs Policies/Plans as necessary.

Qualifications :

Bachelors or Masters degree in Chemistry Biology or a related scientific discipline
15 years of relevant experience in Quality Assurance and/or Quality Control in the pharmaceutical industry.
7 years of prior senior leadership experience.
Deep hands-on knowledge in ICH GMP and regulatory guidance relevant to new drug development and commercialization. Experience with preparing for commercial stage operations and regulatory interactions preferred.
Experience over a broad set of Quality Assurance functions with extensive knowledge of industry best practices and trends.
Ability to understand business objectives and how they translate into quality priorities.
Demonstrated ability to develop a vision for Quality functions as it transitions through the phases of drug development to commercialization.
Demonstrated success in working with and managing CDMOs and external partners using succinct and thorough communication skills.
Demonstrated ability to work independently and efficiently in a collaborative fast-paced integrated multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work.
Demonstrated initiative ownership problem identification problem solving and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met.
Results driven collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks
Excellent verbal and written communication skills with the ability to build productive long-term team relationships at all levels of supplier organizations including with senior executives
Skilled at managing autonomous high-performing professionals who value flexibility while ensuring alignment collaboration and delivery of results.

Additional Information :

Remote Work :

Employment Type :

Full-time

Key Skills

Quality Assurance
FDA Regulations
ISO 9001
Root cause Analysis
Biotechnology
Clinical Trials
Quality Systems
Food Processing
Quality Control
Quality Management
cGMP
HACCP

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About Company

ORIC Pharmaceuticals

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more

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