Sr Mgr Product Quality Integrator

Johnson & Johnson Innovative Medicine; Ringaskiddy; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine is recruiting for a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics. The role has end-to-end accountability for quality strategy from early development through commercialization across Biotherapeutics products.

The position requires a strong background in QA, cGMP, and regulatory submissions, with European-based sites in Cork, Leiden, and other locations. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree in a scientific/technical field and 8+ years in pharma/biotech.
• Knowledge of cGMP standards, policies and procedures.
• Ability to work across organizational boundaries and drive cross-site QA.

Responsibilities

• Owns quality strategy for assigned Biotherapeutics products from development to launch.
• Represents Global Quality on CMC and Value Chain teams; liaises with Analytical groups.
• Reviews and supports regulatory submissions (IND, BLA, NDA, MAA) and agency audits.

Skills

GMP

QMS

CAPA

Regulatory Understanding

Risk Assessment

Cross-functional Collaboration

Decision Making

Problem Solving

Quality Assurance

Communication

Education

Bachelor’s degree (Pharmacy/Biology/Biochemistry/Biotech/Engineering)

Master’s degree preferred

Job description

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:

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 aSenior 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.
• Presents 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

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

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.