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Programme Quality Manager

Posted date Nov. 29, 2024
Contract type Full time
Job ID R-214307
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Why choose AstraZeneca Portugal?

As an exciting and emerging leader in pharma and biotech, we're pushing the boundaries of science to deliver life-changing medicines to patients. This is where breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Voted the best company to work for in Portugal 2023/24, AstraZeneca provides the thrill of a start-up within the security of a global firm that brings new challenges and pathways for a fulfilling career.

If you’re ready to make a difference, join our Global Hub in Corporate Affairs, Human Resources, Finance, Information Technology, Marketing, Global Business Services or Procurement. Bring your potential to our evolving team today.

Who do we look for?

Calling all dynamic, ambitious team players. At AstraZeneca, we empower people like you to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. Here, you'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

We're on the lookout for diverse minds inspired by difference who want to reach another level in their careers. Bold disrupters who confidently rise to challenges as fearless entrepreneurs. People who want to make a meaningful impact led by science in an organisation where global meets local. Join one of our offices in Lisbon and discover a culture of openness and vibrancy where diverse perspectives are encouraged and valued. Your work will have a real impact, no matter your level or function.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Tech innovators

Make a greater impact through our digitally enabled enterprise. If you're technology-savvy and have a digital mindset, you can use your skills and experience to transform and optimise our operations, helping us deliver meaningful work that changes lives.

Dynamic

In a constantly evolving environment dedicated to innovation, you'll use your strong sense of purpose to provide outstanding contributions. Although we're a global company, our Global Hub operates like a start-up, allowing you to work autonomously. Bring your fearlessness of improving patient outcomes, and we'll encourage your personal success.

Ambitious

Play your part in progressing a world-leading pipeline. Here, you'll improve patients' lives now and better the future of humanity. With our opportunities for continuous development, you'll exhibit your passion and potential to go beyond the expected — and grow in your career with our support.

Team players

Your unique perspectives make our ambitions and capabilities possible. Our culture of openness, sharing and giving allows everyone to speak up and express their ideas. In an open atmosphere of camaraderie and support, we rely on each other to further our progress and drive much-needed change.

Responsibilities

Job ID R-214307 Date posted 11/29/2024

As Programme Quality Manager, you will provide oversight and input to cover the qualification/validation of computerised systems according to AstraZeneca SOPs and external regulatory expectations with an emphasis on SAP 4/HANA implementation. You will be responsible for ensuring that the SAP 4/HANA implementation complies with AstraZeneca quality management standards and procedures for this major business transformation. You will have a relentless passion for quality excellence and a strong customer focus. Working with the core team and local organisations, you will be accountable for assuring that the processes and systems are compliant at both the global level (global processes) and the local level (localizations). This includes engaging with senior stakeholders within the business, IT, and Quality functions to ensure that quality and compliance are embedded into the culture, design, and methodology of the programme, balancing quality and compliance requirements with the need for agility and flexibility with conformance to standards.

Accountabilities

• Developing and implementing a computerized system validation approach and assuring the compliance of the processes and systems with GxP and IT standards.

Anticipating early on that the Computerised System Validation requirements and pre-requisites are embedded into the overall programme management methodologies.

• Assuring that programme governance and processes support Computerised System Validation standards.

• Understanding the range of the business and IT requirements, risks, and change impacts associated with fit-to-standard and global process harmonisations.

• Having a strong partnership with senior stakeholders within the business and IT is important to success in this role.

• Liaising with the programme teams and local organizations to ensure compliance is assured for both the global design and localizations.

• Manage Computerised System Validation deliverables acting as AXIAL Project Quality Manager:

  o Creation of key Qualification/Validation documentation.

  o Enforce Computerised System Validation procedures and processes by reviewing and approving project documentation and deliverables such as Specifications, Plans, Reports, etc.

  o Support the creation of Risk Assessment.

  o Provide oversight of Testing Plans and Reports.

  o Ensure completeness and traceability of requirements to testing.

  o Ensure Computerised System Validation best practices are embedded across teams.

  o Foster Good Documentation Practices aligned with ALCOA+ principles.

  o Ensure corporate SOP and supporting templates are used.

  o Advising compliance topics and supporting key decisions related to all regulatory needs (GxP; GDPR; Legal; Data Integrity; Internal Controls, IT Security Controls; etc.)

  o Maintain tools aligned to ways of working, e.g., Solution Manager, Jira, etc.

  o Ensure compliance activities and deliverables are completed as planned.

  o Ensure exceptions and deviations are documented and approved.

  o Provide Computerised System Validation awareness and training.

  o Coordination of and reporting on CSV activities for the SAP S/4HANA implementation.

Essential Skills/Experience

• Deep knowledge and experience of Computerized System Validation. GxP, ALCOA+ and SOx

• Degree and significant experience in life sciences/pharmaceuticals industry.

Demonstrated experience in complex projects and programs.

• Experience of Operations either on business or IT side, ideally in Manufacturing, Quality Management, and Supply Chain Management

• Fluent English 

Highly-analytical with strong attention to detail.

• Excellent communication skills and facilitation skills.

• Experience in global cross-functional and multi-cultural companies.

• Proven track record in navigating complex stakeholder groups.

• A collaborative style and ability to operate successfully in a matrix environment.

Desirable Skills/Experience

Previous experience with SAP, validation, and quality management.

• Good knowledge of Information security, Data privacy, Financial controls.

• Experience with Jira, Solution manager, and testing tool.

• Auditing experience is a plus.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally to succeed together. This is a place of great passion and pride. Where we work hard to build successful, inclusive, and diverse teams that collaborate across the enterprise and beyond. Always striving for better, where new ideas are encouraged, and failure is an anticipated part of our innovation process. Bring out the best in yourself and others. Be open to - and seek out - different thinking to cross-pollinate ideas and approaches. Develop how you work in new ways with partners and collaborators, determined to create an inclusive and equitable environment where people belong. Our culture of recognition and reward means we feel supported and empowered to take the initiative and take responsibility. With all the tools you need to succeed, including constructive coaching, there’s no better place to take ownership of your career and be your best.

Ready to make a difference? Applynow!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

10001146 E FIGE

Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.

Aligned to performance

Our approach is designed to deliver great performance — stimulating our commercial growth, scientific advancement, collaboration and personal development. Never standing still, you'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career.

Balanced

An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. Typical benefits include healthcare, life insurance and long-term savings, and in many markets, there’s a range of benefits for you to tailor.

Holistic

We're at our best and most creative when drawing on our different views, experiences and strengths. Being valued for who you are and the difference you bring is at the heart of our culture — and you’ll be rewarded when you create authentic connections to our purpose.

Sustainable

Our two offices in Lisbon combine comfort with sustainability. From renewable energy, a zero-plastic scheme, electric vehicles and food waste reduction initiatives to sustainable reward practices, we're realising our ambition to harness the power of science to build a healthy future for everyone everywhere.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.