Site Quality Head, Geel

Leads and manages all Quality related programs and activities to support the site and manufacturing operations (commercial & clinical manufacture) at Geel. Functions and activities include Quality Control testing, Quality Assurance review and approval functions, Quality Systems, 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.

You will be responsible for:

• Overall Quality responsible for the Janssen Chemical site in Geel, is accountable for cGMP and the Quality Operations for the chemical operations in Geel for both manufacture of commercial and clinical API’s and drug product intermediates (spray drying).

• Provide 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 Geel site.

• Actively participates as a member of the Geel Site Leadership team and partners with the Site General Manager.

• Serves as a member of the SM Quality Leadership team, to develop common quality strategies across the API sites and the Small Molecule (SM) platform, benchmark best practices internal and external to J&J, work with Compliance team to develop global Quality policies for API SM, assure implementation of these policies and serve as a sponsor to selected processes.

• Partners with other 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 Quality professionals. Hires and develops employees within the department in support of Human Resources planning processes. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.

• Assures the development of all subordinate staff to assume varied future opportunities. Partners with other J&J leaders to assure development opportunities are afforded to key talent. Includes coaching, mentoring, etc.

• Communicates with JNJ Q&S and JJRC ensuring the Geel site is operating within policy framework of J&J Companies.

• Contributes to the development of business and/or functional strategies, including partnering with the site General Manager and API Cluster leadership team and the broader operational organization in developing and 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 handoffs are in place to assure overall organizational effectiveness.

• Establishes and maintains global relationships with partnering organizations and local/regional/national regulatory bodies.

• Analyses regulatory authority’s programs and activities in areas relevant to chemical API products and advises senior and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.

• Creates and monitors adherence to financial budgets and restrictions.

• Supports Quality Process Excellence and Metrics Program.

• Assures that appropriate metrics/targets are established, monitored, and met, including removing barriers.

Qualifications/Requirements

Education and experience:

• B.S. in a scientific/technical discipline with 11–15 years’ experience in a significant leadership position within the chemical and/or pharmaceutical industry, or

• Master’s Degree in scientific/technical discipline with 10+ years above experience.

• 5 years’ experience in a Quality leadership role.

• Significant experience in supporting functional area (e.g., R&D, Manufacturing, Engineering, EH&S, Tech Services) preferred.

• Knowledgeable of FDA/EMA regulatory requirements applicable to chemicals or pharmaceuticals.

• Thorough knowledge of GMPs is required.

• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Leadership Skills

• Excellent written and verbal communication skills with an open, collaborative, interactive leadership style.

• Balanced decision-maker.

• High-energy level with a commitment towards achieving results with strong follow-through.

• 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 and coaching skills.

• 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 industry visibility; credibility with regulatory agencies (e.g., EMA and FDA) is critical.

• Ability to translate strategy into execution and drive results

• Strong integrity and commitment to operating ethically within regulatory boundaries.

• Acts as a role model for J&J Leadership Imperatives.

Other Skills and Qualifications

• Experience working in organizations with strong systems orientation and well-developed Quality Assurance/Compliance programs.

• Strong computer skills (e.g., Word, analytical tools).

• Knowledge of applicable laws and regulations.

• Ability to write reports, business correspondence, and procedure manuals.

• Ability to analyze complex documents (scientific, technical, financial, legal).

• Ability to respond to inquiries from customers, regulatory agencies, and business stakeholders.

• Ability to effectively present information to management, public groups, and boards.

Additional Information

• Requires 5–10% travel.