• Job Title Sr. Director, Site Quality Head, Bern
• Function Quality
• Sub Function Quality Assurance
• Location Berne, Switzerland
• Date Posted Mar 20 2024
• Requisition Number 00001KK4

Description

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong”!

Senior Director, Head of Quality, Bern

The Sr. Director, Head of Quality, Bern leads and manages all aspects of Quality (QA/QC) in support of the Janssen Bern site, and assures compliance with established cGMPs and Janssen Quality requirements. The role defines and implements the appropriate Quality standards for the Bern site and maintains a Quality Management System in compliance with all required regulatory standards and regulations, and Janssen standards, policies and procedures. The role develops and implements long-term strategies, executes the Quality program and ensures a reliable supply of high-quality products to both clinical research and commercial customers through the J&J Supply Chain. The role manages a team of people leaders and technical professionals within QA & QC based on assigned work, direction, coaching and developing capabilities.

Main responsibilities

Site Quality Management:

· Ensures an effective Quality Management System is in place to achieve Janssen Quality objectives and all regulatory requirements and ICH Q10.

· Provides direction to Quality Assurance and Quality Control to ensure the suitability and effectiveness of the QMS and GMP compliance.

· Determines adequate and appropriate resources to implement and maintain an effective Quality Management System.

· Leads, hosts and participates in Quality Management Review to monitor process performance, product quality and the QMS and advocates for continuous improvement of the quality system; ensures timely mitigation of any unfavourable trends.

· Ensures timely and effective communication and escalation regarding quality issues to the appropriate levels of management.

· Assures the required processes, procedures, systems and resources are in place to ensure a compliant manufacturing, testing and distribution process.

· Provides expertise and guidance in interpreting governmental/health authority regulations, agency guidelines and internal procedures to assure continued compliance.

· Hosts all Bern Health Authority inspections and acts as primary spokesperson for the site during inspections.

· Leads and hosts compliance audits including internal audits and regulatory inspections. Proactively develops and sustains strong relationships with regulatory Health Authorities.

· Analyzes regulatory authorities’ programs and activities in areas relevant to Bern products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.

· Maintain quality assurance programs and oversight to ensure that all released products are safe, effective and manufactured in compliance with regulatory requirements worldwide throughout their entire lifecycle.

· Defines departmental strategies for the Site Quality Organization, including Quality Assurance, Quality Systems and related support functions in alignment with the site strategy.

· Serves as process owner for Product Quality Review and Management Review processes; defines key performance indicators (KPIs) for the Quality organization to monitor and improve operational performance.

· Ensures the initial and continuing training of department personnel are carried out and adapted according to business needs.

· Authorizes written procedures and other documents, including amendments.

· Approves and monitors suppliers of materials, contract manufacturers and providers of other GMP-related outsourced activities.

Delegation of Authority:

· Acts as a deputy for the Qualified Person (Fachtechnisch verantwortliche Person) for Janssen Vaccines, Branch of Cilag International GmbH, according to the requirements of the "Bundesgesetz über Arzneimittel und Medizinprodukte” and the "Verordnung über die Bewilligungen im Arzneimittelbereich” and updated versions of these requirements as applicable.

· Decides on product release and rejection of non-conforming product independent from management, and has the decision authority on site for any product, quality and compliance related matters as a deputy for the Qualified Person (Fachtechnisch verantwortliche Person) for Janssen Vaccines, Branch of Cilag International GmbH.

Plant Leadership Team Responsibilities

· Defines and manage targets and objectives for the Bern site as a member of the site leadership team in alignment the company strategy and objectives.

· Sponsors site best practice sharing, harmonization and standardization, LEAN deployment and a continuous improvement mindset.

· Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to turnaround time and business improvement.

· Coordinates Quality related activities among impacted individuals, departments, sites, and companies as needed to proactively support business processes.

Site Quality Team Leadership Responsibilities

· Provides leadership and builds an exceptional team to manage all Quality functions, including hiring, mentoring and developing personnel.

· Champions and fosters a positive quality compliance culture, and diverse and inclusive workplace.

· Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.

· Manages team of senior leaders and professionals within Quality; hires and develops employees within the department.

· Ensuring that the Quality department formation and succession plans are in place.

Advanced Therapies Quality Leadership Responsibilities: As a member of the Advanced Therapies Quality Leadership team (ATQLT), partners with the VP, JSC Quality, Advanced Therapies other JSC Site Quality Heads to ensure harmonization, standardization and alignment with JSC Quality policies, procedures, programs and systems.

Qualifications

· Education : University degree in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline required.

· Experience : At least 12 years working experience in the pharmaceutical industry with demonstrated capability in quality leadership roles. Minimum of 12 years of Quality Assurance / Quality Systems experience related to manufacturing Is required.

· Required skills and knowledge :

o Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems.

o Proven people management and Quality leadership experience.

o Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization.

o Comprehensive regulatory cGMP and technical knowledge to develop operational strategies necessary to maintain the desired level of inspection readiness.

o Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers.

o Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility.

o Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams.

o Extensive knowledge of chemical, biochemical and microbiological concepts.

o Knowledge of cGMP regulations and FDA/EU guidance.

o Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred.

o Fluent in English and German (written and spoken).

· Preferred skills and knowledge:

o Fluency in English required, and conversational German language skills preferred.

o Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change.

o Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment.

o Ability to apply appropriate risk assessment strategies to manage business & compliance priorities.

o Effective negotiation and influencing skills and lead with a mindset of continuous improvement.

o Balanced decision-making skills and ability to effectively resolve conflict, when needed.

o Business acumen; develop and control budgets.

o Ability to communicate effectively with different levels in the organization and with health authorities.

· Other :

o +8 years of People management & Quality leadership experience is required.

o Travel: Occasionally 15%-20%.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.