At a Glance
- Tasks: Ensure high-quality data and compliance in pharmaceutical processes.
- Company: Join a leading pharmaceutical company dedicated to patient well-being.
- Benefits: Competitive salary, bonuses, comprehensive health benefits, and flexible work arrangements.
- Other info: Dynamic role with opportunities for continuous improvement and AI integration.
- Why this job: Make a real impact on patient safety and quality assurance in drug development.
- Qualifications: Bachelor's degree in a relevant field and 5+ years of industry experience.
The predicted salary is between 106200 - 167200 € 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.
Employment Information
- 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.
Equal Employment Opportunity Statement
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 employer: MSD
As a leading employer in the pharmaceutical industry, our company offers a dynamic work environment that prioritises quality assurance and patient well-being. With a strong commitment to employee growth, we provide comprehensive benefits, including competitive salaries, flexible hybrid work arrangements, and opportunities for continuous improvement through innovative tools like AI. Join us to be part of a collaborative culture that values your expertise and fosters professional development in a meaningful and rewarding role.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist Quality Assurance
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the hunt for a Senior Specialist Quality Assurance role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and quality assurance processes. We recommend practising common interview questions related to compliance and quality metrics, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t forget to leverage our website for job applications! It’s super easy to apply directly through us, and you’ll get access to exclusive resources that can help you stand out from the crowd.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in leaving a positive impression. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
We think you need these skills to ace Senior Specialist Quality Assurance
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 key responsibilities mentioned in the job description.
Showcase Your Experience:Don’t just list your previous roles; explain how your experience relates to the pharmaceutical industry and quality agreements. We love seeing specific examples of how you've tackled challenges in past positions.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your communication reflects that, especially since you'll be interacting with various stakeholders.
Apply Through Our Website:We encourage you to submit your application through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss any important updates!
How to prepare for a job interview at MSD
✨Know Your Quality Agreements
Familiarise yourself with the specifics of Quality Agreements, as this role heavily involves generating and negotiating them. Be prepared to discuss your experience with similar agreements and how you’ve ensured compliance in past roles.
✨Showcase Your Regulatory Knowledge
Brush up on EU, US, and ROW regulations related to GMPs. During the interview, demonstrate your understanding of these regulations and how they apply to quality assurance processes in the pharmaceutical industry.
✨Prepare for Cross-Functional Collaboration
This position requires strong teamwork and negotiation skills. Think of examples where you've successfully collaborated with different teams or external stakeholders, and be ready to share how you navigated any challenges.
✨Highlight Process Improvement Initiatives
Be ready to discuss any process improvements you've implemented in previous roles, especially those involving AI tools. Show how you identified opportunities for improvement and the impact it had on efficiency and quality.
