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Senior Qualified Person

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Gilead Sciences

Oct 22

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • Cork
  • Quick Apply

AI generated summary

  • You must have 5+ years in QP release, knowledge of GMPs/GLPs, FDA/EMEA compliance, strong communication skills, and expertise in risk management tools like HACCP/FMEA.
  • You will review and release finished goods, lead investigations, coordinate workloads, collaborate with teams, and ensure compliance with regulatory guidelines and quality standards.

Requirements

  • Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
  • 5+ years of QP Release of Finished goods to Market, including experience in Secondary Packaging operations.
  • This role is an onsite role 5 days a week.
  • Extensive knowledge of FDA / EMEA and other global regulatory compliance guidelines for drug manufacturing, packaging, and distribution.
  • Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
  • Demonstrates ability in managing competing priorities creating an effective team environment.
  • Demonstrates ability to be an influencer without authority.
  • Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
  • Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
  • Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
  • Knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.

Responsibilities

  • QP review and release of Finished Goods to market.
  • Primary QP team representative on the daily Finished Goods Operations Board and supporting meetings.
  • Collaborates closely with the Planning and Packaging functions to schedule and coordinate the workload of the QPs performing release of Secondary Packaged Finished product to the market.
  • Facilitate QP team achieving site Finished Goods release metrics.
  • Serves as a project lead within Finished Good release team.
  • Primary QP contact for investigations impacting Packaging operations at the site.
  • Determines corrective action on investigative findings and with consideration of the long-term impact of decisions.
  • Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors, considerable judgment is required in resolving problems and making routine recommendations.
  • Exercises judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Extensive knowledge of FDA / EMEA and other global regulatory compliance guidelines for drug manufacturing, packaging, and distribution.
  • Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
  • Serves as a point of contact with internal stakeholders and external customers, providing necessary information and troubleshooting to ensure resolution of issues.
  • Demonstrates ability in managing competing priorities creating an effective team environment.
  • Demonstrates ability to be an influencer without authority.
  • Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
  • Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
  • Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
  • Knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.

FAQs

What is the job title for this position?

The job title is Senior Qualified Person.

What qualifications are required for the Senior Qualified Person role?

Candidates must meet the minimum requirements for education and experience outlined in Directive 2001/83/EC relating to medicinal products for human use, along with 5+ years of experience in QP Release of Finished goods to market, including experience in Secondary Packaging operations.

Is this position remote or onsite?

This is an onsite role, requiring presence five days a week.

What are the primary responsibilities of the Senior Qualified Person?

The primary responsibilities include QP review and release of Finished Goods to market, being the primary QP representative on the Finished Goods Operations Board, collaborating with Planning and Packaging functions, facilitating site Finished Goods release metrics, leading projects within the Finished Goods release team, and managing investigations impacting Packaging operations.

What regulatory knowledge is required for this position?

Extensive knowledge of FDA/EMEA and other global regulatory compliance guidelines for drug manufacturing, packaging, and distribution is required.

What skills are essential for this role?

Essential skills include excellent verbal, written, and interpersonal communication skills, the ability to manage competing priorities, knowledge of GMPs and GLPs, and the ability to influence without authority.

Are there any preferred qualifications for the Senior Qualified Person role?

Preferred qualifications include knowledge of Six Sigma, DMAIC methodology, risk management tools such as HACCP or FMEA, and understanding of Information Systems Technology including Computer System Validation (CSV).

How does Gilead handle equal employment opportunities?

Gilead's policy is to recruit, select, and employ the most qualified persons available and administer employment actions non-discriminatorily, without regard to protected characteristics or prohibited grounds as defined by applicable law.

What is the company's mission?

Gilead's mission is to create a healthier world for all people by tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer through the development of life-changing therapies.

Where can current Gilead employees apply for this position?

Current Gilead employees can log onto the Internal Career Site to apply for this job.

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Gilead Sciences

Science & Healthcare
Industry
10,001+
Employees
1987
Founded Year

Mission & Purpose

The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”