Sr Manager QA Operations SSH LVV

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 https://www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 https://www.jnj.com

Sr Manager QA Operations SSH LVV

Essential Job Duties and Responsibilities

The Senior Manager Quality Assurance is responsible that the JBV quality systems are applied as per GMP standards within Janssen Biologics. QA Operations in Sassenheim is the department that supports the manufacturing of Lentiviral vector (LVV) products and delivers quality oversight for the AT QC laboratories. Close collaboration with the production department and the QC Laboratory is required. Functions and activities within the department comprise the full spectrum of Quality processes (e.g. Batch Record Review, Product Release, Changes, Non-Conformances, CAPAs and complaint handling, Process and Cleaning validation, etc). There is a special focus on the institution of shop floor QA for aseptic manufacturing.

We are seeking a dynamic and Senior Manager Quality Assurance to join our team in Sassenheim. In this pivotal role, you will be responsible for the day-to-day Quality Assurance operations for our site, ensuring that all quality standards are met and maintained throughout our operations. The ideal candidate will possess strong leadership skills and has an extensive experience in building and leading Quality teams, a deep understanding of quality management systems, aseptic manufacturing requirements and a commitment to excellence in delivering safe and effective therapies to patients.

Principal responsibilities

• Manages, leads & motivates the QA Operations SSH LVV department and its people to enhance performance and achieve business goals, agreed metrics & budgets
• Leads the Quality team responsible for batch release and QP disposition of the commercial products manufactured at the site
• Manages and improves the GMP processes to facilitate the production and testing of Commercial products at JBV (e.g JJOS)
• Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
• Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the site’s quality systems, projects and programs to maintain GMP compliance, with special focus on Commercial product manufacturing and compliance.
• Supports or leads (global) escalations of issues, which have (potential) impact on the delivery of Commercial Products.
• Replaces other QA MT members, and the SQH when needed
• Participates in quality and capacity projects, and acts as SME on Quality topics
• Supports inspection readiness programs and manages the process during Quality Regulatory inspections

Contacts:

• Operational departments (BU5, BU1 and BU4). Purpose: to ensure quality oversight on the commercial manufacturing and testing activities in these departments and to make sure that the execution is done in line with the regulations and company’s policies and guidelines.
• All GMP departments in the site (BTO, FME, Q&CO sub departments, LO, IT etc.). Purpose: strong collaboration with all departments that contribute to the quality of the clinical and launch products at the site.
• J&J contacts: J&J Corporate Compliance, RA departments and other sister sites. Purpose: to ensure alignment with these sites in the areas of the department’s responsibility.
• Regulatory authorities and 3rd Parties. Purpose: ensure the regulatory expectations of the site’s inspection readiness are met and for an effective execution of regulatory/3rd Party inspections
• Finance Management. Purpose: for budget management
• HR. Purpose: all aspects of people management

Minimum Qualification

• University degree at a master level in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering
• Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations
• Minimum 10 years’ experience in Quality of which 5-7 years in a managerial, people leading role
• Deep understanding and application of Global Regulatory (cGMP/ICHIFDA/EMA) Guidelines in Operations environment.
• Knowledge of/and experience in process development
• Perfect written and oral communication skills in Dutch and English
• Team player, and ready to take a stand when necessary

Other Requirements

• Excellent written and verbal communication skills with an open, collaborative, interactive leadership style.
• Balanced decision-maker.
• Ability to build and nurture strong and positive relationships.
• The ability to work in a team environment and interact with all levels of the organization.
• Results-driven leader who commits to stretch goals and delivers results.
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.

The anticipated base pay range for this position is 80.800 Euro to 140.530 Euro on an annual basis and includes 8% holiday allowance.

Required Skills:

Preferred Skills: