Sr Mgr Product Quality Integrator

8170-Janssen Pharmaceutical Sciences Unlimited Company Legal Entity

Wallingstown

On-site

EUR 120,000 - 160,000

Full time

2 days ago

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Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine (J&J IM) is recruiting a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics. The position will be based at our European sites.

The Senior Manager has end-to-end accountability for quality strategy and QA across Early Development through commercialization in Launch and Grow to Late Stage for biotherapeutics, leading cross-functional teams and ensuring regulatory readiness.

Qualifications

Bachelor's degree in a technical/scientific field.
8+ years in the pharmaceutical/biotech industry with cGMP knowledge.
Ability to influence and partner across organizations.

Responsibilities

Represents Global Quality on CMC and Value Chain teams.
Liaises between VCT and Analytical groups and serves as the Global Quality contact.
Ensures quality stage-gate deliverables are achieved and filings are QA-reviewed.
Defines QA resources and leads a product quality integration team from development to launch.
Supports audits, regulatory filings, and cross-site quality governance.
Drives risk assessment, CAPA, and continuous quality improvement.

Skills

Quality Management

Regulatory Compliance

GMP

Risk Assessment

Cross-functional Collaboration

SOP

CAPA

Quality Auditing

Education

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

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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: Leiden, South Holland, Netherlands, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

Job Description: Johnson & Johnson Innovative Medicine (J&J IM) is recruiting for a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics. The position will be based at our European sites

The Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow to Late Stage for an assigned group of Biotherapeutic (large molecule) products.

Main responsibilities include but are not limited to:

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, device and packaging: development through launch and commercial lifecycle.
Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, device and packaging;
Ensures product quality development through Product Lifecycle.
Supports the sites, represents the sites on CMC and VC teams.
Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Ensures standard Global Quality processes (PPQS, CA, PRA, Complaints, Escalations) are used across sites and facilitates communication throughout Global Quality.
Present project updates to Quality Asset Management for Global Quality alignment.
Drives Decision making and Problem Solving.

Qualifications Required

A minimum of a bachelor’s degree (or University equivalent) 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 in 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 assessment and develop action plans
Flexible hours to accommodate US, EMEA and APAC work schedules when necessary, balancing work and personal time is required
This position will be located in Europe (Cork Ireland, Leiden Netherlands, other) and may require up to 10% domestic and international travel as business demands

Preferred

A Master’s degree or other advanced degree
Knowledge of biotech, biotherapeutics 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 DS, DP and Device stability

Required 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

Base pay range for this position is:

The anticipated base pay range for this position is:

Benefits

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.

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