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

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Directs Managers and/or senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback.
Administers strategy and processes that meet required regulatory standards and Quality Assurance best practices for manufacturing.
Controls resources to deliver policies to assess potential risks in the product lifecycle, including investigations and corrective and preventive actions taken to mitigate risks.
Advises management on systems and processes that follow Quality Assurance best practices, including documentation and auditing.
Communicates strategically with internal legal contacts and external trade and regulatory organizations as appropriate.
Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
Proactively creates a purpose-driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

Johnson and Johnson is hiring a Director, SQ Drug Delivery Systems located in Horsham, PA, Malvern, PA, Titusville, NJ, Raritan, NJ, Beerse, Belgium, Wallingstown, Ireland, San Michelle, Italy, Schafhausen, Switzerland or Leiden, Netherlands!

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-012447
• Belgium - Requisition Number: R-013476
• Switzerland- Requisition Number: R-013478
• Ireland - Requisition Number: R-013481
• Italy - Requisition Number: R-013483
• Netherlands - Requisition Number: R-013487

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

The Director External Quality - Supplier Quality, Drug Delivery Systems (DDS) provides leadership in directing a group of Supplier Quality (SQ) professionals located globally across regions where JNJ operates, including SQ Account Managers, Subject Matter Experts (SMEs), and People Leaders.

Key Responsibilities:

• Establishes strategy and owns the design, development, and execution of an efficient End-to-End operating model for the External Quality oversight of suppliers related to Drug Delivery System (DDS) components of combination products.
• Establishes relevant policies, procedures and processes, and ensuring alignment among IMSC functions involved in this area, including but not limited to Global Procurement, PQM, DPDS, MSAT, and other Internal and External Quality functions within IM.
• Partners with Research & Development (R& D) technical and quality design teams to assure commercial considerations for design specification development, material sourcing, manufacturing and quality and compliance are included at the earliest stage of design control possible
• Partners with DPDS, Procurement, Internal IMSC sites and other key DDS development stakeholders to assure Supplier Quality Management activities are executed with DDS suppliers including: quality agreements, specification agreements, audits, supply chain identification, qualification, change control, investigations, risk assessments, and complaints.
• Ensures reporting on supplier performance and issues via metrics and participation in management reviews, monitoring trends, identifying issues, recommending and implementing appropriate actions as related to suppliers and IMSC sites.
• Promotes pro-active quality culture via engagements with suppliers and other internal partners to achieve objectives.
• Supports issues related to DDS suppliers globally. Escalates issues as appropriate to Senior Management and supervises timely mitigation of quality components of escalation
• Coaches, leads, and develops SQ professionals handling DDS supplier accounts
• Actively participates on the Supplier Quality Leadership Team.
• Represents External Quality (EQ) and Supplier Quality (SQ) in various IMSC, Pharmaceutical sector, and J& J regional forums and councils.

Qualifications

Education:

• A minimum of Bachelor degree (BS/BA); preferred subjects include science, engineering, or technical areas.

Experience and Skills:

Required:

• A minimum of 12+ years experience in biologics, drug product, drug substance, medical device, vaccines or similar regulated environment; preferred experience in Quality and Compliance
• In-depth knowledge and experience with global regulatory cGMP, ISO 13485 requirements, and regulatory requirements related to Combination Products development (GMP & GCP)
• Experience and knowledge in device component design and/or combination product design and commercialization is required
• Demonstrated strategic thinking capabiliti define a strategy and vision for the future.
• Demonstrated experience managing external business partners.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external partners.
• Excellent computer proficiency e.g. MS Office.

Preferred:

• People leadership experience managing individuals/teams preferred

Other:

• Requires up to 10% of domestic travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.