Johnson & Johnson Careers
Senior Director, Quality Site Head
Requisition ID: 1905752105W
Leads and manages all Quality related programs and activities to support the site and manufacturing operations at Leiden. Functions and activities include Quality Assurance review and approval functions, compliance activities, Product Release activities, etc. Ensures business, quality and compliance goals are met in full compliance with all J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines.
Overall QA responsible for the Janssen Biologics site in Leiden. Provides overall leadership and direction to the quality organization, building processes to improve the capabilities of the organization.
Assures appropriate processes and resources are in place and effective to deliver a sound compliance profile in the Leiden site.
Actively participates as a member of the Site Leadership Team and partners with the Site General Manager.
Serves as a member of the API Quality Leadership team, to develop common quality strategies across the API large molecule (LM) platform, benchmark best practices internal and external to J&J, work with Compliance team to develop global Quality policies for API LM, assure implementation of these policies and serve as a sponsor to selected processes.
Partners with other JSC Site Quality Heads and Global Quality to ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.
Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement
Directly supervises a team of senior managers and professionals with Quality. Hires and develops employees within the department in support of Human Resources Planning (HRP). Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
Assures the development of all subordinate staff to assume varied future opportunities. Partner with other J&J leaders to assure development opportunities are afforded to key talent. Includes coaching, mentoring, etc.
Communicate with JJSC Quality and Compliance Worldwide, JSC, ensuring the Leiden site is operating within policy framework of J&J Companies.
Contributing to the development of business and/or functional strategies, including partnering with the site General Managers and the broader operational organization in developing the executing the operational strategy and creating future opportunities.
Explore synergies and barriers to supply chain and development interactions. Build processes to assure that appropriate touch points and hand offs are in place to assure overall organizational effectiveness.
Establishes and maintains global relationships with partnering organizations and local/regional/national regulatory bodies.
Analyzes regulatory authorities’ programs’ and activities and in areas relevant to biological 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.
Creates the budget and monitors adherence to financial goals and restrictions.
Develops the tactical and operational plans for the quality department(s) and ensure that tactical objectives are met in support of strategic targets.
Responsible for the overall management and effectiveness of the corrective action and preventive action (CAPA) and risk management processes.
Plan, organize, and oversee programs that will ensure the Leiden site’s compliance to regulatory standards, including EMA and FDA, as a business sustainable advantage.
Provide technical leadership in administration of Leiden’s Quality Assurance functions supporting manufacturing efforts.
Establishing “Best practices” for GMP facilities that will ensure consistency between manufacturing sites.
Oversees and leads quality investigations and/or internal audits to assess conformance to specifications, company procedures and overall compliance to regulations.
Oversees and ensures proper execution and compliance in complaint handing investigations.
Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools. Presents case studies and metrics to management.
Oversees the quality review resulting from statistical and data analyses for projects, involving the design, development or validation of new or existing products and processes.
Leads cross-functional teams and provides subject matter expertise to other departments.
Create customer-focused quality systems that ensure GMP compliance and facilitate business needs.
Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
Assures that all assigned personnel have the appropriate training and qualifications to perform all duties and responsibilities. Complies with own training requirements to perform duties or own job.
Carries out duties in compliance with all local/regional/national regulations and guidelines including EMA, FDA, … complies with all company and site policies and procedures.
Successfully completes regulatory and job training requirements.
Understands and responsibly performs duties with attention to quality, safety and environmental matters.
EDUCATION AND EXPERIENCE:
Master’s degree in scientific/technical discipline with 10+ years within the biological and/or pharmaceutical industry.
5 years’ experience in a Quality leadership role.
Significant experience in supporting functional area (e.g. R&D, Manufacturing, Engineering, EHS, or Technical Services) preferred.
Knowledgeable of FPD/EMA regulatory requirements applicable to biologics or pharmaceuticals. A thorough knowledge of GMPs is required. Ability to apply GMP regulations and other FDA and internal guidelines to all aspects of the position.
Excellent written and verbal communication skills with an open, collaborative, interactive leadership style.
A high energy level with a commitment towards achieving results with outstanding follow through skills is required.
Ability to build and nurture strong and positive relationships.
Demonstrated strategic thinking capabilities and the ability to help define a vision for the future.
Team collaboration skills and coaching skills.
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.
External relationships and visibility in the industry. Credibility with regulatory agencies (eg. EMA and FDA) is critical.
Ability to translate strategy to execution and drive and the organization forward in executing and delivering results.
An unquestionable level of integrity and commitments to operating ethically and within the boundaries of regulatory requirements.
Experience working with an organization with a strong systems orientation and well-developed Quality Assurance programs are essential.
Computer skills: ability to use software programs including word processing and mathematical applications and customize them for business purposes.
Knowledge of applicable laws and regulations.
Ability to write reports, business correspondence and procedure manuals.
Read, analyze, and interpret complex documents such as scientific and technical journals, financial reports, and legal documents.
Respond to sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community.
Effectively present information to management, public groups, and/or boards of directors.
PHYSICAL REQUIMENTS/WORKING CONDITIONS:
Require 5-10% travel.
Janssen Biologics (7266)