Associate Director, External Quality Control
Halozyme, Inc.
5 months ago
Remote friendly (San Diego, CA)
United States
Operations
How You Will Make An Impact
- Provide a full range of External Quality Control (QC) activities supporting Halozyme’s ENHANZE programs across commercial, clinical, and development products and programs.
- Oversee Drug Substance (DS) and Drug Product (DP) Contract Manufacturing Organizations (CMOs) producing and testing Halozyme products, including supervision of staff.
In This Role, You’ll Have The Opportunity To
- Direct, lead, and develop a team of QC associates; mentor and provide growth opportunities.
- Direct and manage technical external QC activities during GMP analyses (e.g., technical data review for in-process, release, and stability; support method transfers, qualifications, validations, and QA technical interactions).
- Support CMOs with QC-related investigations and analytical method issues.
- Lead external QC activities, meet delivery dates, and lead technical areas across all programs while ensuring adherence to cGMP requirements at CMOs.
- Manage change controls for CMO analytical methods and laboratory impacting activities.
- Support QC/analytical aspects of new product scale-up, process improvement, technology transfer, and process-validation.
- Provide and manage required documentation: review/revision of procedures and specifications, annual product reviews, and support regulatory filing documents.
- Coordinate specification document updates for control system review and shelf life/retest updates.
- Communicate changes with partners; address partner regulatory information and program change requests.
- Author and/or review QC and analytical-related regulatory sections.
- Perform external audits/vendor qualifications (audit agendas and reports); support internal audits via audit readiness, responding to inquiries, and post-audit actions.
- Initiate QC-related CAPAs to maintain internal quality systems.
- Maintain awareness of analytical and regulatory developments.
- Develop/revise/implement/adhere to departmental policies and procedures affecting Quality.
- Contribute to the department budgeting process.
To Succeed In This Role, You’ll Need
- Bachelor’s degree in a scientific subject area or engineering; 10 years proven experience (combination of education and experience may be considered).
- Strong background in analytical chemistry, microbiology, and biologics technologies; pharmaceutical QC experience.
- Demonstrated experience leading reference standard and stability programs.
- Expert writing and reviewing regulatory filings.
- Detailed understanding of GMPs, ICH guidelines, and regulatory guidelines.
- Ability to independently schedule, track, review, and report complex external QC activities.
- Ability to work closely with internal departments, partners, and CMOs (including senior management).
- Effective problem-solving and negotiation skills.
Preferred
- Working knowledge and experience in QC assay development, qualification, and validation.
- Experience with external parties (CMOs, Contract Labs).
- Knowledge of statistical software (e.g., JMP) and QMS (e.g., MasterControl).
In Return, We Offer You
- Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
- Opportunities to grow (learning/development, in-house programs, tuition reimbursement).
Application Instructions
- Save time and apply through your LinkedIn account by using the “Apply with LinkedIn” button; your LinkedIn profile will be imported into the site.
- Provide a full range of External Quality Control (QC) activities supporting Halozyme’s ENHANZE programs across commercial, clinical, and development products and programs.
- Oversee Drug Substance (DS) and Drug Product (DP) Contract Manufacturing Organizations (CMOs) producing and testing Halozyme products, including supervision of staff.
In This Role, You’ll Have The Opportunity To
- Direct, lead, and develop a team of QC associates; mentor and provide growth opportunities.
- Direct and manage technical external QC activities during GMP analyses (e.g., technical data review for in-process, release, and stability; support method transfers, qualifications, validations, and QA technical interactions).
- Support CMOs with QC-related investigations and analytical method issues.
- Lead external QC activities, meet delivery dates, and lead technical areas across all programs while ensuring adherence to cGMP requirements at CMOs.
- Manage change controls for CMO analytical methods and laboratory impacting activities.
- Support QC/analytical aspects of new product scale-up, process improvement, technology transfer, and process-validation.
- Provide and manage required documentation: review/revision of procedures and specifications, annual product reviews, and support regulatory filing documents.
- Coordinate specification document updates for control system review and shelf life/retest updates.
- Communicate changes with partners; address partner regulatory information and program change requests.
- Author and/or review QC and analytical-related regulatory sections.
- Perform external audits/vendor qualifications (audit agendas and reports); support internal audits via audit readiness, responding to inquiries, and post-audit actions.
- Initiate QC-related CAPAs to maintain internal quality systems.
- Maintain awareness of analytical and regulatory developments.
- Develop/revise/implement/adhere to departmental policies and procedures affecting Quality.
- Contribute to the department budgeting process.
To Succeed In This Role, You’ll Need
- Bachelor’s degree in a scientific subject area or engineering; 10 years proven experience (combination of education and experience may be considered).
- Strong background in analytical chemistry, microbiology, and biologics technologies; pharmaceutical QC experience.
- Demonstrated experience leading reference standard and stability programs.
- Expert writing and reviewing regulatory filings.
- Detailed understanding of GMPs, ICH guidelines, and regulatory guidelines.
- Ability to independently schedule, track, review, and report complex external QC activities.
- Ability to work closely with internal departments, partners, and CMOs (including senior management).
- Effective problem-solving and negotiation skills.
Preferred
- Working knowledge and experience in QC assay development, qualification, and validation.
- Experience with external parties (CMOs, Contract Labs).
- Knowledge of statistical software (e.g., JMP) and QMS (e.g., MasterControl).
In Return, We Offer You
- Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
- Opportunities to grow (learning/development, in-house programs, tuition reimbursement).
Application Instructions
- Save time and apply through your LinkedIn account by using the “Apply with LinkedIn” button; your LinkedIn profile will be imported into the site.