At a Glance
- Tasks: Lead compliance projects and ensure quality standards in drug development.
- Company: Join Pfizer, a leader in healthcare innovation and patient-centric solutions.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Be part of a diverse team committed to excellence and innovation.
- Why this job: Make a real impact on patient access to life-changing medicines and vaccines.
- Qualifications: Strong experience in regulatory compliance and quality oversight required.
The predicted salary is between 80000 - 100000 € per year.
Use Your Power for Purpose At Pfizer, we are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.
Your role will involve interpreting federal, state, and international regulations as they apply to our products, processes, practices, and procedures. You will investigate and resolve compliance issues both within and outside of Pfizer, ensuring that our commitment to excellence and integrity remains steadfast.
The Quality Oversight and Compliance Director is responsible for developing and maintaining Quality Plans, ensuring inspection and audit readiness, providing quality oversight of process deviations, investigations and associated corrective and preventive actions, and driving compliance of pan-regulatory (e.g. Manufacturing, Regulatory Strategy, CMC, Submissions, Clinical) information and processes globally.
The Quality Oversight and Compliance Director works to instil a quality mindset by ensuring the quality and compliance of regulatory processes and product/license information through clearly defined and documented metrics, identifying data trends and addressing associated process risks in collaboration with Regulatory Process Business Process Owners (BPOs) and stakeholders.
The Quality Oversight and Compliance Director works with Regulatory Process BPOs and stakeholders to identify and investigate procedural/compliance gaps and deviations, identify root cause and establish/monitor appropriate remediation plans through timely completion. The Quality Oversight and Compliance Director supports and drives implementation of inspection readiness, audit preparedness and training compliance.
What You Will Achieve
- Develop and lead/co-lead highly complex projects, creating mid-term plans that impact results and drive innovation.
- Identify critical quality process parameters/KPIs to ensure data and process quality and collaborate to create associated Quality Plans and metric reports/dashboards.
- Provide oversight of existing and input to planned processes/systems/controls to ensure that quality is built-in to enable consistent compliance.
- Identify procedural/compliance gaps associated with in scope processes and establishes mitigation and remediation plans with BPOs that provide optimal balance of compliance and business need.
- Drive the investigation, remediation and closeout of Quality Events and associated corrective and preventive actions.
- Drive and support inspection readiness activities and provide remediation support for audit (or inspection) findings.
- Identify opportunities for improvement of pan-regulatory data and business processes and procedures through the definition, management and analysis of metric data in collaboration with BPOs and other stakeholders.
- Leverage relationships to meet the needs of various business units, serving as an advisor and influencing management decisions.
- Make decisions in complex problems, recommend innovative solutions, and support in solving issues impacting business units.
- Act independently on self-initiated projects, using knowledge and judgment in complex decisions within business units.
- Guide Pfizer by interpreting regulations and designing compliance programs, conducting audits, and evaluating policies.
- Provide expertise on quality standards, support partner functions globally, and drive risk management and quality oversight.
Here Is What You Need (Minimum Requirements)
- A BA/BS with at least strong experience or an MBA/MS with strong experience or a PhD/JD with experience or an MD/DVM with some experience.
- Profound knowledge of drug development, license maintenance processes, regulatory codes, guidance, and technologies.
- Experience with standard tools of continuous improvement and quality investigations, including DMAIC, root cause analysis, interview techniques and human performance analysis.
- Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and provide consultation as a scientific/technical resource for assigned projects.
- Familiarity with systems and electronic technologies that support regulatory activities.
- Ability to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs and established deadlines.
- Ability to work effectively within or lead a team in a matrix structure.
- Ability to influence without authority.
- Proficiency in Microsoft Office.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
Bonus Points If You Have (Preferred Requirements)
- A Master's degree (MA/MBA/MS) with over 12 years of experience or a Doctorate (PhD/PharmD/JD) with more than 9 years of experience.
- Proficiency in Lean and/or Six Sigma methodologies.
- Experience in engaging with the external regulatory and pharmaceutical environment.
- A solid understanding of the business and financial landscape.
- Strategic thinking and the ability to develop innovative solutions.
- Experience in risk management and quality oversight.
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
- Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
Work Location Assignment: Hybrid
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.
Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.
Lets start the conversation!
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.
DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Quality Oversight and Compliance Director in Oxford employer: Pfizer
At Pfizer, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters innovation and collaboration. Our commitment to employee growth is evident through our comprehensive training programmes and opportunities for advancement, all while ensuring a flexible work environment that promotes work-life harmony. Join us in making a meaningful impact on global health as we strive to deliver life-changing medicines with integrity and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Oversight and Compliance Director in Oxford
✨Tip Number 1
Network like a pro! Reach out to current or former Pfizer employees on LinkedIn. Ask them about their experiences and any tips they might have for landing a role in Quality Oversight and Compliance. Personal connections can give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for the interview by diving deep into Pfizer's values and mission. Think about how your experience aligns with their commitment to excellence and integrity. Be ready to share specific examples of how you've navigated compliance issues in the past.
✨Tip Number 3
Show off your analytical skills! During interviews, be prepared to discuss how you've used data to drive quality improvements or compliance initiatives. Bring up any tools or methodologies you're familiar with, like DMAIC or root cause analysis, to demonstrate your expertise.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're genuinely interested in being part of the Pfizer team. Make sure to tailor your application to highlight your relevant experience in regulatory processes and quality oversight.
We think you need these skills to ace Quality Oversight and Compliance Director in Oxford
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Quality Oversight and Compliance Director role. Highlight your relevant experience and skills that align with Pfizer's commitment to excellence and integrity.
Showcase Your Knowledge:Demonstrate your understanding of regulatory codes and drug development processes in your application. Use specific examples from your past experiences to illustrate how you've navigated compliance issues successfully.
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language to communicate your qualifications and avoid jargon unless it's industry-specific and relevant.
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application is seen by the right people and gives you the best chance to showcase your skills and passion for the role.
How to prepare for a job interview at Pfizer
✨Know Your Regulations
Familiarise yourself with the federal, state, and international regulations relevant to Pfizer's products. Be prepared to discuss how these regulations impact quality oversight and compliance, and think about examples from your past experience where you successfully navigated complex regulatory landscapes.
✨Showcase Your Analytical Skills
Prepare to demonstrate your analytical and problem-solving skills during the interview. Bring specific examples of how you've used tools like DMAIC or root cause analysis in previous roles to drive compliance and improve processes. This will show that you can think critically and act decisively.
✨Communicate Effectively
Practice articulating complex issues clearly and concisely. Since you'll be communicating with various stakeholders, it’s essential to convey your thoughts in a way that aligns with their understanding. Consider role-playing with a friend to refine your communication style.
✨Emphasise Team Collaboration
Highlight your ability to work within or lead a team in a matrix structure. Share examples of how you've influenced colleagues without authority and collaborated with cross-functional teams to achieve compliance goals. This will demonstrate your leadership potential and teamwork skills.
