Quality Associate III

Vantive; Hinoba-an; On-site; PHP 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Vantive is seeking a senior QA professional to oversee analytical operations and ensure data integrity for global registrations. You will review method validation, stability studies, and CoAs, while supervising investigations into OOS/OOT and ensuring GMP/GLP compliance.

You will mentor teams, manage data integrity risks, and collaborate with regulatory affairs to align with the regulatory plan and external quality standards as required.

Qualifications

• 10+ years in Analytical chemistry and/or QA roles.
• 4–6 years in QA oversight of analytical functions with exposure to E&L studies.
• Strong experience in regulatory submissions and product registrations.
• GMP/GLP knowledge, ICH guidelines and pharmacopeias.
• Ability to lead others in small projects.
• Excellent interpersonal, communication and problem-solving skills.
• Working knowledge of FDA regulations.

Responsibilities

• Provide QA oversight for analytical laboratories (internal and external).
• Review and Approve analytical method validation protocols and reports, stability study protocols and reports, specifications and CoA.
• Review and Approve extractables and leachables study plans, protocols, and reports.
• Review and approve investigations for OOS, OOT, Deviations and Incidents.
• Ensure all analytical work complies with GMP, GLP, and data integrity principles.
• Monitor lab compliance and drive quality improvements.
• Ensure analytical data meets requirements for global registrations (US FDA, EMA, ROW).
• Participate in health authority inspections and audits.
• Ensure integrity and traceability of analytical data (ALCOA+).
• Oversee electronic systems qualifications & usage such as LIMS, ELN, and data management tools.
• Identify and mitigate data integrity risks.
• Lead investigations related to data inconsistencies.
• Perform CAPA reviews and provide input to management reviews.
• Support CRO OOL, OOS and provide insight to ongoing Investigations and SCARs.
• Responsible for the compliance and approval of PDLM records, per Vantive procedures throughout the product lifecycle.
• Collaborate with regulatory affairs to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment.
• Collaborate with teams to provide strategy and guidance for meeting Vantive Requirements and External Quality Standards as appropriate.

Skills

Analytical techniques

Method validation

Analytical equipment qualification

Stability studies

Impurity profiling

GMP/GLP knowledge

ICH guidelines

Communication skills

Analytical thinking

FDA regulations

Leadership

Tools

LIMS

ELN

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary

Responsible for ensuring that all analytical activities, data, and documentation meet global quality and regulatory requirements. This role plays a critical part in supporting product registrations by ensuring analytical data integrity, compliance, and audit readiness.

Essential Duties and Responsibilities

• Provide QA oversight for analytical laboratories (internal and external).

• Review and Approve Analytical method validation protocols and reports, Stability study protocols and reports, Specifications and test methods and Certificates of analysis (CoA).
• Review and Approve extractables and leachables study plans, protocols, and reports.
• Review and approve investigations for; OOS (Out of Specification), OOT (Out of Trend), Deviations and Incidents.
• Ensure all analytical work complies with GMP, GLP, and Data Integrity principles.

• Monitor lab compliance and drive quality improvements.

• Ensure analytical data meets requirements for global registrations (e.g., US FDA, EMA, ROW).

• Participate in health authority inspections and audits.

• Ensure integrity and traceability of analytical data (ALCOA+ principles).

• Oversee electronic systems qualifications & usage such as LIMS, ELN, and data management tools.

• Identify and mitigate data integrity risks.

• Lead investigations related to data inconsistencies.

• Perform CAPA reviews and provide input to management reviews.

• Support CRO OOL, OOS and provide insight to the ongoing Investigations and SCAR’s.

• Responsible for the compliance and approval of PDLM records, per Vantive procedures throughout the product lifecycle.
• Collaborate with regulatory affairs as needed to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment.
• Collaborate with teams to provide strategy and guidance for meeting Vantive Requirements and External Quality Standards as appropriate.

Qualification

• Strong knowledge of:
  • Analytical techniques (HPLC, GC, spectroscopy, dissolution),
  • Method validation and Method transfer,
  • Analytical Equipment Qualification,
  • Stability studies and impurity profiling,
• Deep understanding of GMP / GLP requirements, ICH guidelines (Q2, Q6, Q7, Q8, etc.) and,Global pharmacopeias (USP, EP, BP) not limited to USP <1663>, <1664>
• Good interpersonal/communication/influencing/negotiation skills.
• Good analytical and problem solving skills.
• Working knowledge of FDA Regulations.
• Demonstrated ability to lead others within small project or investigational environments.

Education and Experience

10+ years in Analytical chemistry and/or QA roles.

Minimum 4–6 years in QA oversight of analytical functions and exposure to E&L studies or related fields (container closure, packaging, or impurity analysis).

Strong experience in regulatory submissions and product registrations

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, click on the link here and let us know the nature of your request along with your contact information.