Gilead.com
Overview
Director, Product Quality Lead role at Gilead. On-site position based at Foster City headquarters. The PQL is a strategic leadership position responsible for end-to-end product quality strategy, serving as the primary Quality representative on the PDM Product Strategy Team(s) and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and provide effective quality oversight and feedback by liaising between Product Strategy Team, Manufacturing, Analytical, Supply Chain, RA CMC, and the wider PDM Quality organization. Experience in biotechnology and pharmaceutical development and strong knowledge of cGMP quality systems are required. Gilead’s mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.
On-site position based at Foster City headquarters.
Job Functions
Accountable for end-to-end quality compliance of the assigned product/program, including providing strategic leadership and direction for quality and compliance activities and owning the overall product risk log.
Serve as the primary Quality representative in the PDM meeting.
Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
Monitor and review cross-functional process and product data to identify trends to identify and mitigate significant quality and compliance risks, escalating as needed.
Review and approve the strategy for change controls impacting the product/program lifecycle.
Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
Contribute to regulatory submissions (IND, IMPD, BLA, NDA, MAA) and assist with regulatory communications as needed.
Provide oversight for changes to drug substance and drug product CMC details.
Accountable for PAI/PLI readiness and support inspection preparation and post-inspection follow-up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead sites.
Support drug substance and drug product technology transfer and new product launches.
Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.
Accountable for medical device/combination product quality compliance and liaison with medical device product engineering, development, and quality teams.
Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
Perform work that requires independent decision making and independent judgment.
Serve as the delegate for Pillar Lead, as needed, for meetings and decision making.
Knowledge, Experience And Skills
In-depth understanding and application of GMP principles and standards in the US and internationally.
Ability to develop and improve complex concepts, techniques, and standards based on quality principles.
Knowledge of global requirements/standards for product registration and lifecycle management of product quality.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
Skilled at managing multiple projects and timelines and facilitating meetings.
Understanding and execution of Quality Risk Management.
Ability to track and follow up on actions.
Excellent verbal, written and interpersonal communication skills.
Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.
Ability to lead and influence a matrix-based cross-functional team.
Critical and strategic thinking with the ability to provide pragmatic, risk-based, and phase-appropriate guidance.
Basic Qualifications
12+ years of relevant experience and a Bachelors degree in science or related fields.
Or 10+ years of relevant experience and an advanced science degree (MS, MD).
Or 8+ years of relevant experience and a PharmD or PhD in science or related fields.
Or 8+ years of relevant experience and an advanced business degree such as an MBA.
Preferred Qualifications
15+ years of relevant experience with a Bachelors degree in science or related fields.
Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.
Direct experience with regulatory health authority submissions (IND, NDA, BLA, MAA) and/or inspections.
Prior Quality leadership and technical management experience in development and/or commercial programs.
People Leader Accountabilities
Create Inclusion - model inclusion and embed value of diversity in team management.
Develop Talent - understand skills and aspirations, coach for current performance and future potential.
Empower Teams - align goals and remove barriers to connect teams to the broader ecosystem.
Compensation and Benefits The salary range for this position is: $210,375.00 - $272,250.00. This position may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants and fostering an inclusive work environment. Recruitment and selection will be conducted without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics in accordance with applicable laws. Reasonable accommodations for applicants protected by applicable laws may be requested via ApplicantAccommodations@gilead.com.
Our environment respects individual differences and celebrates the diversity of thoughts and opinions. If you are a current Gilead employee or contractor, please apply via the Internal Career Opportunities portal in Workday.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Product Management and Marketing
Industries: Pharmaceutical Manufacturing
California City, CA — Salary: $210,375 - $272,250. 1 month ago.
#J-18808-Ljbffr
Director, Product Quality Lead role at Gilead. On-site position based at Foster City headquarters. The PQL is a strategic leadership position responsible for end-to-end product quality strategy, serving as the primary Quality representative on the PDM Product Strategy Team(s) and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and provide effective quality oversight and feedback by liaising between Product Strategy Team, Manufacturing, Analytical, Supply Chain, RA CMC, and the wider PDM Quality organization. Experience in biotechnology and pharmaceutical development and strong knowledge of cGMP quality systems are required. Gilead’s mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.
On-site position based at Foster City headquarters.
Job Functions
Accountable for end-to-end quality compliance of the assigned product/program, including providing strategic leadership and direction for quality and compliance activities and owning the overall product risk log.
Serve as the primary Quality representative in the PDM meeting.
Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
Monitor and review cross-functional process and product data to identify trends to identify and mitigate significant quality and compliance risks, escalating as needed.
Review and approve the strategy for change controls impacting the product/program lifecycle.
Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
Contribute to regulatory submissions (IND, IMPD, BLA, NDA, MAA) and assist with regulatory communications as needed.
Provide oversight for changes to drug substance and drug product CMC details.
Accountable for PAI/PLI readiness and support inspection preparation and post-inspection follow-up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead sites.
Support drug substance and drug product technology transfer and new product launches.
Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.
Accountable for medical device/combination product quality compliance and liaison with medical device product engineering, development, and quality teams.
Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
Perform work that requires independent decision making and independent judgment.
Serve as the delegate for Pillar Lead, as needed, for meetings and decision making.
Knowledge, Experience And Skills
In-depth understanding and application of GMP principles and standards in the US and internationally.
Ability to develop and improve complex concepts, techniques, and standards based on quality principles.
Knowledge of global requirements/standards for product registration and lifecycle management of product quality.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
Skilled at managing multiple projects and timelines and facilitating meetings.
Understanding and execution of Quality Risk Management.
Ability to track and follow up on actions.
Excellent verbal, written and interpersonal communication skills.
Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.
Ability to lead and influence a matrix-based cross-functional team.
Critical and strategic thinking with the ability to provide pragmatic, risk-based, and phase-appropriate guidance.
Basic Qualifications
12+ years of relevant experience and a Bachelors degree in science or related fields.
Or 10+ years of relevant experience and an advanced science degree (MS, MD).
Or 8+ years of relevant experience and a PharmD or PhD in science or related fields.
Or 8+ years of relevant experience and an advanced business degree such as an MBA.
Preferred Qualifications
15+ years of relevant experience with a Bachelors degree in science or related fields.
Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.
Direct experience with regulatory health authority submissions (IND, NDA, BLA, MAA) and/or inspections.
Prior Quality leadership and technical management experience in development and/or commercial programs.
People Leader Accountabilities
Create Inclusion - model inclusion and embed value of diversity in team management.
Develop Talent - understand skills and aspirations, coach for current performance and future potential.
Empower Teams - align goals and remove barriers to connect teams to the broader ecosystem.
Compensation and Benefits The salary range for this position is: $210,375.00 - $272,250.00. This position may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants and fostering an inclusive work environment. Recruitment and selection will be conducted without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics in accordance with applicable laws. Reasonable accommodations for applicants protected by applicable laws may be requested via ApplicantAccommodations@gilead.com.
Our environment respects individual differences and celebrates the diversity of thoughts and opinions. If you are a current Gilead employee or contractor, please apply via the Internal Career Opportunities portal in Workday.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Product Management and Marketing
Industries: Pharmaceutical Manufacturing
California City, CA — Salary: $210,375 - $272,250. 1 month ago.
#J-18808-Ljbffr