DIRECTOR OF QUALITY ASSURANCE
Planet Pharma · San Francisco, CA · 3 wk ago
On-siteQuality AssuranceFull-time
We need to output HTML fragment with sections only if real content. Use for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to extract content.
Job posting includes: Position Title, Position Summary, Essential Duties And Responsibilities, Essential Skills & Qualifications, IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco. Also location, category, salary: Apply for details (no actual salary). So we should not create Pay or Schedule sections unless actual content. There's no explicit Pay or Schedule details besides "IN OFFICE PRESENCE" which is schedule? It's office presence days. Could be considered schedule but it's not explicit schedule like full-time/part-time. The instruction: never create Pay/Schedule/Benefits sections unless posting actually states them. It does state "IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco". That is schedule info (office days). Might be considered schedule. However they said "Schedule" heading for schedule info. Could include that. But we need to see if it's real specific content: yes, specific days. So we can include a Schedule section with that.
Benefits: none mentioned. So omit Benefits.
Pay: "Salary: Apply for details" is not specific; it's placeholder. So we should not create Pay section because it's not substantive (just "Apply for details").
Thus sections: About the role (position summary), Responsibilities (essential duties), Requirements (maybe combine essential skills & qualifications?), Qualifications (maybe degree etc), Skills (maybe skills list). But we need to avoid thin sections. Could combine Requirements and Qualifications and Skills into one? But headings are prescribed; we can use them if we have content. We have content for Responsibilities, Essential Skills & Qualifications (which includes qualifications, skills, etc). Could split: Requirements (maybe education/experience), Qualifications (maybe advanced degree preferred), Skills (maybe technical skills). But risk of thin sections. Better to have a few substantive sections: About the role (position summary), Responsibilities (essential duties), Requirements (education + experience + certifications), Skills (technical & soft skills). Could also include Schedule.
Let's parse content:
Position Summary: "The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities. We are a commercial and development stage company with an approved complex drug-device combination product and a development pipeline of device products. The Director of Quality Assurance manages the Quality Management System, QA personnel, and Quality initiatives, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. S/he translates the company’s quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global standards and ensure the overall quality of products. S/he will collaborate closely with the Head of Quality and Regulatory Affairs, internal functional areas, external partners, contract facilities, and suppliers to drive continuous improvement in quality and support regulatory compliance and product safety from early product development through the post-marketing stage of product lifecycles."
Essential Duties And Responsibilities: list of many items (each sentence). We'll put as
for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to extract content.
Job posting includes: Position Title, Position Summary, Essential Duties And Responsibilities, Essential Skills & Qualifications, IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco. Also location, category, salary: Apply for details (no actual salary). So we should not create Pay or Schedule sections unless actual content. There's no explicit Pay or Schedule details besides "IN OFFICE PRESENCE" which is schedule? It's office presence days. Could be considered schedule but it's not explicit schedule like full-time/part-time. The instruction: never create Pay/Schedule/Benefits sections unless posting actually states them. It does state "IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco". That is schedule info (office days). Might be considered schedule. However they said "Schedule" heading for schedule info. Could include that. But we need to see if it's real specific content: yes, specific days. So we can include a Schedule section with that.
Benefits: none mentioned. So omit Benefits.
Pay: "Salary: Apply for details" is not specific; it's placeholder. So we should not create Pay section because it's not substantive (just "Apply for details").
Thus sections: About the role (position summary), Responsibilities (essential duties), Requirements (maybe combine essential skills & qualifications?), Qualifications (maybe degree etc), Skills (maybe skills list). But we need to avoid thin sections. Could combine Requirements and Qualifications and Skills into one? But headings are prescribed; we can use them if we have content. We have content for Responsibilities, Essential Skills & Qualifications (which includes qualifications, skills, etc). Could split: Requirements (maybe education/experience), Qualifications (maybe advanced degree preferred), Skills (maybe technical skills). But risk of thin sections. Better to have a few substantive sections: About the role (position summary), Responsibilities (essential duties), Requirements (education + experience + certifications), Skills (technical & soft skills). Could also include Schedule.
Let's parse content:
Position Summary: "The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities. We are a commercial and development stage company with an approved complex drug-device combination product and a development pipeline of device products. The Director of Quality Assurance manages the Quality Management System, QA personnel, and Quality initiatives, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. S/he translates the company’s quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global standards and ensure the overall quality of products. S/he will collaborate closely with the Head of Quality and Regulatory Affairs, internal functional areas, external partners, contract facilities, and suppliers to drive continuous improvement in quality and support regulatory compliance and product safety from early product development through the post-marketing stage of product lifecycles."
Essential Duties And Responsibilities: list of many items (each sentence). We'll put as - .
Essential Skills & Qualifications: includes bullet-like sentences but not formatted as list. We'll extract each requirement as list items.
List items from that paragraph:
- Bachelor level degree in a relevant scientific discipline; advanced degree is preferred
- Minimum of 10 years of Quality Assurance experience, with at least 5 years in a management role
- Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages is required; experience with combination products is desired
- Experience implementing Quality systems at virtual organizations (e.g., specification developer)
- Expert knowledge of US FDA Regulatory requirements (cGMP / GLP / GCP / GVP / QMSR / ISO) and other applicable (e.g., international) standards of compliance
- Experience applying risk management principles to decision making
- Experience engaging vendors and CMOs, including relationship management and performance monitoring
- Ability and willingness to be certified as a Designated Representative for a Wholesaler through the CA State Board of Pharmacy
- Availability for travel, both domestic and international
- Requires strong organizational and technical skills (e.g., word processing, spreadsheets, databases, online research)
- Experience with Veeva QMS is preferred
- Requires excellent verbal, written, and communication skills
- Ability to prioritize multiple assignments in a fast-pace office environment and communicate those priorities within the department, to leadership, and across cross-functional teams
- Ability to effectively communicate with and manage multiple external partners and teams, locally and globally, including availability for collaboration across multiple time zones
- Ability to work independently and as a team player cross-functionally
- Ability to effectively manage and lead the department and, when needed, cross-functional teams
- Ability to effectively develop a department and its personnel, including coaching and mentoring
Also "IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco" -> schedule.
We'll create sections:
About the role
position summary
Responsibilities
- ... each duty
Requirements
maybe include education, experience, certifications, travel availability. Could combine degree, years experience, management experience, certification ability, travel availability.
Skills
include technical skills, Veeva QMS, communication, organizational, risk management, vendor management, etc.
We need to avoid duplication. Ensure we preserve all substantive info. Let's list duties exactly as in text.
Duties list (each sentence separated by period). We'll copy them.
1. Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements.
2. Create, maintain, review, and approve GXP-related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents.
3. Leads the programs and processes within the QMS, including change control, deviations and investigations, complaints, CAPAs, metrics and reporting.
4. Develops and manages GXP training programs for personnel in collaboration with the other functional heads.
5. Maintain and implement the supplier qualification program, including conducting supplier audits, developing quality agreements, and monitoring supplier performance.
6. Implements the internal audit program.
7. Serves as the primary back-up system administrator for the Veeva EDMS.
8. Ensures inspection readiness and, in coordination with the Head of Quality and Regulatory Affairs, manages regulatory inspections and audits.
9. Develops and implements strategies for continuous quality improvement to support evolving regulations, product innovation, and a strong Quality culture across the organization.
10. Provides Quality and CMC guidance and oversight during new product due diligence, product development, and commercialization.
11. Provides Quality guidance for clinical studies to ensure GCP compliance, qualification of suppliers, and execution of SOPs
12. Performs product release for investigational and commercial distribution.
13. Oversees product complaints and reviews post-marketing surveillance reports.
14. Works closely with the Regulatory function to develop Quality and CMC content for submissions, manage DHFs, address Quality and CMC information in information requests, and represent the Quality function in regulatory interactions.
15. Participate in supply chain planning and commercial distribution activities.
16. Monitors and assesses the impact of new regulatory requirements on the company, QA function, and product pipeline.
17. Establishes and maintains the internal library of standards and technical publications
18. Manages relationships with external quality partners, including vendors and consultants
19. Oversees the effective administration of the internal EDMS for the company.
20. Manages and mentors QA personnel for career development and advancement.
Check for any missing: also "Manages and mentors QA personnel for career development and advancement." Already.
Now Requirements: Let's extract:
- Bachelor level degree in a relevant scientific discipline; advanced degree is preferred
- Minimum of 10 years of Quality Assurance experience, with at least 5 years in a management role
- Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages is required; experience with combination products is desired
- Experience implementing Quality systems at virtual organizations (e.g., specification developer)
- Expert knowledge of US FDA Regulatory requirements (cGMP / GLP / GCP / GVP / QMSR / ISO) and other applicable (e.g., international) standards of compliance
- Experience applying risk management principles to decision making
- Experience engaging vendors and CMOs, including relationship management and performance monitoring
- Ability and willingness to be certified as a Designated Representative for a Wholesaler through the CA State Board of Pharmacy
- Availability for travel, both domestic and international
That's 9 items.
Skills: Could include:
- Requires strong organizational and technical skills (e.g., word processing, spreadsheets, databases, online research)
- Experience with Veeva QMS is preferred
- Requires excellent verbal, written, and communication skills
- Ability to prioritize multiple assignments in a fast-pace office environment and communicate those priorities within the department, to leadership, and across cross-functional teams
- Ability to effectively communicate with and manage multiple external partners and teams, locally and globally, including availability for collaboration across multiple time zones
- Ability to work independently and as a team player cross-functionally
- Ability to effectively manage and lead the department and, when needed, cross-functional teams
- Ability to effectively develop a department and its personnel, including coaching and mentoring
That's 8 items.
Now schedule: "IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco". We'll put in Schedule section.
Now ensure we don't include boilerplate like Equal Opportunity Employer, Fraud Alert, etc.
Now produce HTML fragment.
We'll wrap each section in appropriate tags.
Make sure not to repeat job title as heading.
We'll output:
About the role
The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities. We are a commercial and development stage company with an approved complex drug-device combination product and a development pipeline of device products. The Director of Quality Assurance manages the Quality Management System, QA personnel, and Quality initiatives, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. S/he translates the company’s quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global standards and ensure the overall quality of products. S/he will collaborate closely with the Head of Quality and Regulatory Affairs, internal functional areas, external partners, contract facilities, and suppliers to drive continuous improvement in quality and support regulatory compliance and product safety from early product development through the post-marketing stage of product lifecycles.
Responsibilities
- Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements.
- Create, maintain, review, and approve GXP-related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents.
- Leads the programs and processes within the QMS, including change control, deviations and investigations, complaints, CAPAs, metrics and reporting.
- Develops and manages GXP training programs for personnel in collaboration with the other functional heads.
- Maintain and implement the supplier qualification program, including conducting supplier audits, developing quality agreements, and monitoring supplier performance.
- Implements the internal audit program.
- Serves as the primary back-up system administrator for the Veeva EDMS.
- Ensures inspection readiness and, in coordination with the Head of Quality and Regulatory Affairs, manages regulatory inspections and audits.
- Develops and implements strategies for continuous quality improvement to support evolving regulations, product innovation, and a strong Quality culture across the organization.
- Provides Quality and CMC guidance and oversight during new product due diligence, product development
About the role
position summary
Responsibilities
- ... each duty
Requirements
maybe include education, experience, certifications, travel availability. Could combine degree, years experience, management experience, certification ability, travel availability.Skills
include technical skills, Veeva QMS, communication, organizational, risk management, vendor management, etc. We need to avoid duplication. Ensure we preserve all substantive info. Let's list duties exactly as in text. Duties list (each sentence separated by period). We'll copy them. 1. Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. 2. Create, maintain, review, and approve GXP-related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents. 3. Leads the programs and processes within the QMS, including change control, deviations and investigations, complaints, CAPAs, metrics and reporting. 4. Develops and manages GXP training programs for personnel in collaboration with the other functional heads. 5. Maintain and implement the supplier qualification program, including conducting supplier audits, developing quality agreements, and monitoring supplier performance. 6. Implements the internal audit program. 7. Serves as the primary back-up system administrator for the Veeva EDMS. 8. Ensures inspection readiness and, in coordination with the Head of Quality and Regulatory Affairs, manages regulatory inspections and audits. 9. Develops and implements strategies for continuous quality improvement to support evolving regulations, product innovation, and a strong Quality culture across the organization. 10. Provides Quality and CMC guidance and oversight during new product due diligence, product development, and commercialization. 11. Provides Quality guidance for clinical studies to ensure GCP compliance, qualification of suppliers, and execution of SOPs 12. Performs product release for investigational and commercial distribution. 13. Oversees product complaints and reviews post-marketing surveillance reports. 14. Works closely with the Regulatory function to develop Quality and CMC content for submissions, manage DHFs, address Quality and CMC information in information requests, and represent the Quality function in regulatory interactions. 15. Participate in supply chain planning and commercial distribution activities. 16. Monitors and assesses the impact of new regulatory requirements on the company, QA function, and product pipeline. 17. Establishes and maintains the internal library of standards and technical publications 18. Manages relationships with external quality partners, including vendors and consultants 19. Oversees the effective administration of the internal EDMS for the company. 20. Manages and mentors QA personnel for career development and advancement. Check for any missing: also "Manages and mentors QA personnel for career development and advancement." Already. Now Requirements: Let's extract: - Bachelor level degree in a relevant scientific discipline; advanced degree is preferred - Minimum of 10 years of Quality Assurance experience, with at least 5 years in a management role - Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages is required; experience with combination products is desired - Experience implementing Quality systems at virtual organizations (e.g., specification developer) - Expert knowledge of US FDA Regulatory requirements (cGMP / GLP / GCP / GVP / QMSR / ISO) and other applicable (e.g., international) standards of compliance - Experience applying risk management principles to decision making - Experience engaging vendors and CMOs, including relationship management and performance monitoring - Ability and willingness to be certified as a Designated Representative for a Wholesaler through the CA State Board of Pharmacy - Availability for travel, both domestic and international That's 9 items. Skills: Could include: - Requires strong organizational and technical skills (e.g., word processing, spreadsheets, databases, online research) - Experience with Veeva QMS is preferred - Requires excellent verbal, written, and communication skills - Ability to prioritize multiple assignments in a fast-pace office environment and communicate those priorities within the department, to leadership, and across cross-functional teams - Ability to effectively communicate with and manage multiple external partners and teams, locally and globally, including availability for collaboration across multiple time zones - Ability to work independently and as a team player cross-functionally - Ability to effectively manage and lead the department and, when needed, cross-functional teams - Ability to effectively develop a department and its personnel, including coaching and mentoring That's 8 items. Now schedule: "IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday in San Francisco". We'll put in Schedule section. Now ensure we don't include boilerplate like Equal Opportunity Employer, Fraud Alert, etc. Now produce HTML fragment. We'll wrap each section in appropriate tags. Make sure not to repeat job title as heading. We'll output:About the role
The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities. We are a commercial and development stage company with an approved complex drug-device combination product and a development pipeline of device products. The Director of Quality Assurance manages the Quality Management System, QA personnel, and Quality initiatives, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. S/he translates the company’s quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global standards and ensure the overall quality of products. S/he will collaborate closely with the Head of Quality and Regulatory Affairs, internal functional areas, external partners, contract facilities, and suppliers to drive continuous improvement in quality and support regulatory compliance and product safety from early product development through the post-marketing stage of product lifecycles.
Responsibilities
- Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements.
- Create, maintain, review, and approve GXP-related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents.
- Leads the programs and processes within the QMS, including change control, deviations and investigations, complaints, CAPAs, metrics and reporting.
- Develops and manages GXP training programs for personnel in collaboration with the other functional heads.
- Maintain and implement the supplier qualification program, including conducting supplier audits, developing quality agreements, and monitoring supplier performance.
- Implements the internal audit program.
- Serves as the primary back-up system administrator for the Veeva EDMS.
- Ensures inspection readiness and, in coordination with the Head of Quality and Regulatory Affairs, manages regulatory inspections and audits.
- Develops and implements strategies for continuous quality improvement to support evolving regulations, product innovation, and a strong Quality culture across the organization.
- Provides Quality and CMC guidance and oversight during new product due diligence, product development