QA Validation Manager

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

Job Title : Quality Assurance Validation Manager

Department: Quality

Position Reports to: QA Senior Manager

Job Purpose:

The purpose of the role is to provide Quality support for the introduction & validation of new systems and quality oversight in maintaining the validation life cycle of existing systems.

For new projects, the role involves QA leadership in relation to design/enabling/operational readiness works to support the validation of new systems according to Pfizer Quality Standards (PQS) and Grange Castle Standard Operating Procedures (GC SOP). The QA Manager represents Quality and Compliance requirements throughout the project life-cycle from design through to operational handover, working in partnership with the engineers, operations, technical services and contract personnel.

 Job Responsibilities:

Represent QA at product, technical and robustness team meetings and lead/drive all associated support activities. Act as delegate for QA senior manager as required.

Participate in cross-functional teams as required where strategic leadership is required.

Appropriately delegate workload to drive project timelines in a compliant manner, based on experience, knowledge and history of previous projects. Identify strengths and talents within the team drive this delegation.

Contribute to promoting a ‘Right First Time’ and ‘Continuous Improvement culture’ with the project quality and wider teams, by using analytical tools, introduction / updating of site systems and solutions

Liaise between the team and all customers both internal and external.

Support key stakeholders with investigations and resolution of discrepancies. To provide consultative support on quality related issues to Validation activities.

Ensure that manufacturing operations and documentation of manufacturing activities are performed in a manner which is compliant with Pfizer Quality Standards and Grange Castle Standard Operating Procedures.

Represent and support the team to ensure team, Quality OpU and site metrics are met.

Ensure issues are escalated as appropriate to QA Senior Manager and SQOL, and that feedback is sought in a timely manner.

Ensure weekly, monthly, quarterly and annual reports are generated in a timely manner as Use visual management to track and trend activities required.

Regularly report out to management on achievements and challenges.

Ensure that GC Quality system SOP (Deviations, Change Control) are applied as appropriate in the project lifecycle

Lead continuous inspection readiness for QA

Drive a culture of continuous improvement within QA

Challenge and develop talent QA Specialist team.

Enhance agility and flexibility within the team and across teams.

Perform and assist with additional duties as may be directed by the QA Lead for Tech Transfers.

Education/Experience

Hold a B.Sc. degree in biological/chemical sciences or other related technical degree or equivalent experience in regulated industry.

Preferably 5-10 years quality experience in a biotech, pharmaceutical, or bio- pharmaceutical manufacturing environment.

Role requires experience in Integrated Commissioning and Qualification Strategies (ASTM E2500 and ISPE focused), demonstrated knowledge in Computer system validation and GAMP regulations

Experience of involvement in technical issue resolution, in a multidisciplinary environment

Excellent communication and interpersonal skills.

Demonstrated ability to successfully collaborate, influence and lead in a matrix organization

Proven record in demonstrating agility

Work Location Assignment: Flexible

All applicants must have relevant authorization to live and work in Ireland.

Additional Information

In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

Please note there is no relocation support available for this position

How to apply

Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

Job Title : Quality Assurance Validation Manager

Department: Quality

Position Reports to: QA Senior Manager

Job Purpose:

The purpose of the role is to provide Quality support for the introduction & validation of new systems and quality oversight in maintaining the validation life cycle of existing systems.

For new projects, the role involves QA leadership in relation to design/enabling/operational readiness works to support the validation of new systems according to Pfizer Quality Standards (PQS) and Grange Castle Standard Operating Procedures (GC SOP). The QA Manager represents Quality and Compliance requirements throughout the project life-cycle from design through to operational handover, working in partnership with the engineers, operations, technical services and contract personnel.

 Job Responsibilities:

• Represent QA at product, technical and robustness team meetings and lead/drive all associated support activities. Act as delegate for QA senior manager as required.

• Participate in cross-functional teams as required where strategic leadership is required.

• Appropriately delegate workload to drive project timelines in a compliant manner, based on experience, knowledge and history of previous projects. Identify strengths and talents within the team drive this delegation.

• Contribute to promoting a ‘Right First Time’ and ‘Continuous Improvement culture’ with the project quality and wider teams, by using analytical tools, introduction / updating of site systems and solutions

• Liaise between the team and all customers both internal and external.

• Support key stakeholders with investigations and resolution of discrepancies. To provide consultative support on quality related issues to Validation activities.

• Ensure that manufacturing operations and documentation of manufacturing activities are performed in a manner which is compliant with Pfizer Quality Standards and Grange Castle Standard Operating Procedures.

• Represent and support the team to ensure team, Quality OpU and site metrics are met.

• Ensure issues are escalated as appropriate to QA Senior Manager and SQOL, and that feedback is sought in a timely manner.

• Ensure weekly, monthly, quarterly and annual reports are generated in a timely manner as Use visual management to track and trend activities required.

• Regularly report out to management on achievements and challenges.

• Ensure that GC Quality system SOP (Deviations, Change Control) are applied as appropriate in the project lifecycle

• Lead continuous inspection readiness for QA

• Drive a culture of continuous improvement within QA

• Challenge and develop talent QA Specialist team.

• Enhance agility and flexibility within the team and across teams.

• Perform and assist with additional duties as may be directed by the QA Lead for Tech Transfers.

Education/Experience

• Hold a B.Sc. degree in biological/chemical sciences or other related technical degree or equivalent experience in regulated industry.

• Preferably 5-10 years quality experience in a biotech, pharmaceutical, or bio- pharmaceutical manufacturing environment.

• Role requires experience in Integrated Commissioning and Qualification Strategies (ASTM E2500 and ISPE focused), demonstrated knowledge in Computer system validation and GAMP regulations

• Experience of involvement in technical issue resolution, in a multidisciplinary environment

• Excellent communication and interpersonal skills.

• Demonstrated ability to successfully collaborate, influence and lead in a matrix organization

• Proven record in demonstrating agility

Work Location Assignment: Flexible

All applicants must have relevant authorization to live and work in Ireland.

Additional Information

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

• Please note there is no relocation support available for this position

How to apply

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.