Sr Mgr Product Quality Integrator

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 114.000 - 170.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine is seeking a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics at our European sites. You will own end-to-end quality strategy across Early Development through commercialization for assigned Biotherapeutic products, supporting CMC, regulatory filings, and global QA processes.

Travel up to 10% is expected as collaboration spans Global Quality and external partners.

Qualifikationen

• Bachelor's degree in a relevant technical/scientific field.
• 8+ years in pharma/biotech industry.
• Knowledge of cGMP standards.
• Ability to collaborate across organizational boundaries.
• Willingness to travel up to 10%.

Aufgaben

• Represents Global Quality on CMC and Value Chain teams.
• Ensures QA deliverables are achieved across products.
• QA reviewer/approver of health authority filings and support audits.
• Defines QA resources for global and local QA of assigned products.
• Leads Quality integration teams across development to launch lifecycle.

Ausbildung

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

Jobbeschreibung

All Job Posting Locations

Leiden, South Holland, Netherlands, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

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 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.
• 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

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

The anticipated base pay range for this position is

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.