Senior Manager, Quality Assurance

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Lead and provide support for essential QMS processes, which encompass Management Review and Annual Product Quality Reviews (APQRs).

• Evaluate batch documentation and assist in commercial product release operations, including handling deviations, implementing CAPA, and managing change control.

• Organize, perform, and follow up on internal audits, supplier audits, and regulatory inspections.

• Propel continuous improvement initiatives and facilitate quality risk management.

• Oversee supplier management activities, including qualification, performance assessment, and updates to quality agreements.

• Aid in GDP compliance programs, which cover transportation and distribution oversight, warehousing tasks, temperature excursion management, customer qualification, and recall preparedness.

• Guarantee adherence to data integrity standards and governance of computerized systems, electronic records, and electronic signatures.

• Work collaboratively with Regulatory Affairs, Manufacturing, Supply Chain, Distribution, and other cross-functional teams to ensure compliant product release and distribution operations.

• Recognize, evaluate, and escalate quality and compliance risks as necessary.

⛳️ Requirements

• A Bachelor’s degree in a Health Science discipline is required; a Master’s degree is preferred. Equivalent combinations of education and relevant experience will be taken into account.

• At least 5 years of experience in the pharmaceutical manufacturing sector, focusing on quality assurance.

• Comprehensive knowledge of EU GMP (EudraLex Volume 4), EU GDP Guidelines (2013/C 343/01), Directive 2001/83/EC, ICH Q7, Q9, and Q10, along with other pertinent regulatory requirements.

• Demonstrated experience in managing outsourced GMDP activities.

• Practical experience with electronic quality management systems such as Veeva Vault, TrackWise, or similar platforms.

• Strong organizational and project management capabilities, with the ability to juggle multiple priorities effectively.

• Exceptional attention to detail and a strong commitment to quality.

• Proficient in negotiation and stakeholder management.

• Capability to independently evaluate complex situations, resolve problems, and propose practical solutions.

• Strong risk-based decision-making and problem-solving skills.

• Excellent written and verbal communication abilities, with the capacity to present complex information to varied audiences.

• Proven ability to forge collaborative relationships and work effectively across functions and with external partners.

🏝️ Benefits

• Competitive base salary, bonus, new hire, and ongoing equity packages.

• Medical, dental, and vision insurance.

• Employer-funded life, disability, business travel, and EAP coverage.

• 401(k) Plan with a fully vested company match of 1:1 up to 5%.

• Employee Stock Purchase Plan with a 2-year purchase price lock-in.

• Over 15 vacation days.

• 13 to 15 paid holidays, including office closure between December 24th and January 1st.

• 10 days of paid sick leave.

• Paid parental leave benefit.

• Tuition assistance.