Director, SQ Drug Delivery Systems

Johnson & Johnson; Horsham; On-site; USD 146,000 - 252,000; Full time

Job summary

An established industry player is seeking a Director of Supplier Quality for Drug Delivery Systems. This pivotal role involves leading a global team of Supplier Quality professionals, ensuring compliance with regulatory standards, and fostering a proactive quality culture. You will collaborate with cross-functional teams to enhance supplier quality management and drive strategic initiatives. Join a forward-thinking organization dedicated to innovation in healthcare, where your expertise will directly impact patient outcomes and the future of medicine. If you're ready to make a difference and lead a dynamic team, this opportunity is for you.

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid vacation

Sick leave

Performance bonuses

Flexible working hours

Employee wellness programs

Professional development opportunities

Qualifications

• 12+ years experience in biologics or medical devices.
• In-depth knowledge of global regulatory requirements.
• Experience in combination product design is essential.

Responsibilities

• Lead Supplier Quality professionals globally.
• Establish strategies for quality oversight of suppliers.
• Promote a proactive quality culture with suppliers.

Skills

cGMP knowledge

ISO 13485 compliance

Supplier Quality Management

Quality Assurance

Regulatory requirements

Strategic thinking

Communication skills

Team leadership

Education

Bachelor's degree in Science

Bachelor's degree in Engineering

Technical degree

Tools

MS Office

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

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.

• Establishes strategy and leads 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. This role involves establishing 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 escalations related to DDS suppliers globally. Escalates issues as appropriate to Senior Management and oversees prompt mitigation of quality components of escalation
• Coaches, leads, and develops SQ professionals managing 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.

ohnson 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 ([e-mail]) 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.

The anticipated base pay range for this position is :

$146,000-$251,850

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

ohnson 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 ([e-mail]) 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.