Senior Manager, Quality Asset Management

Johnson & Johnson Innovative Medicine; Brussel; Sur place; EUR 96 000 - 165 000; Plein temps

Avantages offerts par ce poste

Vacation days

Parental leave

Well-being programs

Annual bonus

Insurance plans

Résumé du poste

Johnson & Johnson Innovative Medicine is hiring a Senior Manager, Quality Asset Management for Advanced Therapies. The role provides end-to-end accountability for quality strategy from development through commercialization across sites and countries.

You will lead global quality teams, ensure stage-gate deliverables, review regulatory filings, and drive risk-based decision making with cross-functional colleagues in CMC and VCT teams.

Qualifications

• Bachelor’s degree with major in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering or similar.
• Minimum 8 years’ experience in pharmaceutical/biotech industry.
• Knowledge of cGMP standards, policies and procedures.
• Ability to work across organizational boundaries through influencing and partnering.
• Ability to assimilate new technologies, perform risk assessments and develop action plans.
• Travel up to 10% domestically and internationally.

Responsabilités

• Represents Global Quality on CMC and Value Chain Teams; liaison with Analytical group.
• Ensure Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (IND/IMPD/MAA) and related questions.
• Define and oversee QA resources for global and local QA of assigned products.
• Lead QA teams for development through launch across multiple modalities.
• Ensure standard Global Quality processes are used and communicate across sites.
• Present project updates to Global Quality for alignment.
• Drive decision making and problem solving within Quality.

Connaissances

Leadership

Cross-functional collaboration

GMP knowledge

Regulatory understanding

Risk assessment

Communication

Quality mindset

Formation

Bachelor's degree in Pharmacy/Biology/Biochemistry/Biotechnology/Engineering

Master’s degree (preferred)

Description du poste

Senior Manager, Quality Asset Management

Aug 24, 2026

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Job Description:

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-094866

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Senior Manager, Quality Asset Management has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Advanced Therapies products.

Key Responsibilities:

Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact.

Ensures Quality stage gate deliverables are achieved.

Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned.

Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.

Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.

Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:

Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.

Represents Global Quality on the Value Chain Teams (VCT):

Presents project updates to QM for Global Quality alignment:

Drives Decision making and Problem Solving:

Qualifications

Required

A minimum of a bachelor’s degree with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration

A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry

Knowledge of cGMP standards, policies and procedures

Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering

Ability to quickly assimilate new technologies, perform risk assessments and develop action plans

Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required

This position may require up to 10% of domestic and international travel as business demands

Preferred

A Master’s degree or other advanced degree

Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing

Experience in technology transfer, process development and/or process validation

In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies

Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities

Experience in API and Drug Product stability

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Alignment, Collaboration, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

The anticipated pay range for this position, in the primary posting location, is:

The anticipated pay ranges for additional locations are:

[Belgium] – The anticipated base pay range for this position is 96,000 EUR– 165,025 EUR.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Johnson & Johnson Innovative Medicine leads in scientific advancements, developing transformative treatments with compassion to address complex diseases and improve patient lives worldwide.

Pharmaceutical Manufacturing Chemical Manufacturing Manufacturing

Company size 10,001+ employees

Company type Privately held

Momentum

Team growth

Momentum

5% in 12 mo

38,463 employees on LinkedIn

Feb 23 Apr 26