At a Glance
- Tasks: Ensure high-quality data and compliance in the pharmaceutical industry through effective quality assurance processes.
- Company: Join a leading pharmaceutical company committed to patient rights and well-being.
- Benefits: Competitive salary, comprehensive benefits, hybrid work options, and annual bonuses.
- Other info: Opportunity for career growth and continuous improvement in a supportive team.
- Why this job: Make a real impact on patient safety and quality in a dynamic environment.
- Qualifications: Bachelor’s degree and 5+ years in pharma; strong teamwork and negotiation skills required.
The predicted salary is between 80000 - 125000 € per year.
Quality Assurance protects patient rights and well-being, supports compliance with global regulatory requirements through effective processes and procedures, and provides independent assurance of high-quality data and clinical supplies.
Key Responsibilities
- Generate, negotiate, review, assess, and approve Quality Agreements between our company’s research labs and its contractors, cross-site and division teams supporting clinical supply production.
- Generate, negotiate, review, and approve assessments for audit refusal and other related quality events at suppliers of GMP materials and services.
- Serve as quality representative in meetings with internal and external stakeholders, including Quality Disposition and Pharmaceutical Research/Development.
- Communicate clearly and effectively with internal and external stakeholders.
- Collect and track Quality Agreement metrics and other operational metrics.
- Act as TPQM gatekeeper and review GLOSS SOP changes, updates, and new SOPs for TPQM impact or awareness.
- Collaborate with internal teams and external contractor personnel on tailgate sampling, reduced testing assessments, risk assessments, supply chain mapping, and annual report authorship.
Key Activities
- Maintain the Quality Agreement Master List and related trackers with accuracy.
- Support internal audits and inspections as needed.
- Use, support, and continuously improve TPIC (Third Party Information Center) to enable TPQM workflows and operations.
- Collect and track third-party oversight related metrics.
- Identify and implement process improvements, including opportunities to leverage AI tools.
- Communicate with senior company leadership and contractor management.
- Prepare and present cross-functional management updates.
- Make independent decisions and act with appropriate authority.
- Identify trends and potential compliance gaps and lead issue resolution to improve quality and efficiency.
- Interpret regulatory requirements and communicate them effectively across stakeholders.
Qualifications
- Bachelor’s degree in engineering, biology, chemistry or a related field.
- Minimum of 5 years of relevant experience within the pharmaceutical industry, or an advanced degree with at least 5 years of relevant experience.
Preferred Experience & Skills
- Ability to independently engage with external parties.
- Strong cross-functional teamwork, collaboration, influence, and negotiation skills.
- Strong knowledge of EU, US, and ROW regulations and application of GMPs in an R&D environment.
- Knowledge of drug development process.
- Knowledge of continuous improvement methods; able to identify opportunities and implement solutions.
- Experience with AI tools applications to streamline workflows and replace manual work with automation when applicable.
- Strong organizational and time-management skills; able to deliver well-defined projects within area of expertise.
- Ability to manage conflicting priorities proactively.
- Proficient with Microsoft 365 Office applications (e.g., PowerPoint, Word, Excel).
Required Skills
- Adaptability
- Audits
- Compliance
- Continuous Process Improvement
- Data Analysis
- Detail-Oriented
- Deviation Management
- Drug Development
- Due Diligence
- Employee Training Programs
- GMP Auditing
- GMP Compliance
- Internal Auditing
- Interpersonal Relationships
- Manufacturing Processes
- Manufacturing Quality Control
- Microsoft Word
- Negotiation
- Pharmaceutical Management
- Pharmaceutical Research
- Process Improvements
- Quality Assurance (QA)
- Quality Assurance Systems
- Quality Risk Management
- Regulatory Requirements
Benefits
- Salary range: $106,200.00 – $167,200.00. Eligible for annual bonus and long-term incentive, if applicable.
- Comprehensive benefits include medical, dental, vision, health-care and other insurance benefits (for employee and family), retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.
Employee status: Regular. Relocation: No relocation. Visa sponsorship: No. Travel requirements: 10%. Flexible work arrangements: Hybrid. Shift: 1st – Day. Valid driving license: No. Hazardous material: No. Job posting end date: 05/29/2026.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
Senior Specialist Quality Assurance in London employer: MSD
As a Senior Specialist in Quality Assurance, you will thrive in a dynamic work environment that prioritises patient rights and regulatory compliance. Our company offers a comprehensive benefits package, including competitive salaries, flexible hybrid work arrangements, and opportunities for professional growth through continuous improvement initiatives. Join us to be part of a collaborative culture that values innovation and empowers employees to make impactful decisions.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist Quality Assurance in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its quality assurance processes. Be ready to discuss how your experience aligns with their needs, especially around compliance and regulatory requirements.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share examples of how you've identified compliance gaps or implemented process improvements in your previous roles. This will demonstrate your proactive approach.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our team and contributing to quality assurance.
We think you need these skills to ace Senior Specialist Quality Assurance in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in quality assurance and compliance. We want to see how your skills align with the responsibilities listed in the job description, so don’t hold back!
Showcase Your Experience:When detailing your work history, focus on your relevant experience in the pharmaceutical industry. We’re particularly interested in your ability to manage quality agreements and your knowledge of GMPs, so make those stand out!
Be Clear and Concise:In your written application, clarity is key! Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that communicates your qualifications effectively.
Apply Through Our Website:We encourage you to submit your application through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people!
How to prepare for a job interview at MSD
✨Know Your Quality Agreements
Make sure you understand the ins and outs of Quality Agreements, as this role heavily revolves around generating, negotiating, and approving them. Brush up on your knowledge of GMP regulations and be ready to discuss how you've handled similar agreements in the past.
✨Showcase Your Communication Skills
Since you'll be communicating with various stakeholders, practice articulating complex regulatory requirements clearly and effectively. Prepare examples of how you've successfully navigated challenging conversations or negotiations in previous roles.
✨Demonstrate Your Problem-Solving Abilities
Be prepared to discuss specific instances where you've identified compliance gaps or implemented process improvements. Highlight your experience with AI tools and how they've helped streamline workflows in your previous positions.
✨Prepare for Cross-Functional Collaboration
This role requires strong teamwork and collaboration skills. Think of examples where you've worked with diverse teams or external contractors, and be ready to explain how you managed conflicting priorities while delivering successful outcomes.
