Senior Manager Quality Assurance

at  Johnson Johnson

Johnson & Johnson is currently seeking Senior Manager Quality Assurance to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.
While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Come join our dynamic team at Johnson & Johnson as a Quality Assurance Senior Manager at our new Large Molecule Drug Substance Manufacturing facility! We are seeking a talented and passionate professional who thrives in a fast-paced environment and is committed to ensuring the highest standards of quality throughout our organization. If you have a keen eye for detail, exceptional problem-solving skills, and a proven track record in quality assurance, this is the perfect opportunity for you to make a lasting impact.
As the Quality Assurance Senior Manager, you will be responsible for leading our quality assurance department to ensure compliance with regulatory requirements, industry standards, and internal SOPs. You will play a vital role in driving continuous improvement initiatives and fostering a culture of quality throughout the organization.

Essential Job Duties and Responsibilities:

• Develop and implement a comprehensive quality assurance strategy, aligning it with the company’s objectives and regulatory guidelines. Stay up to date with industry best practices and ensure that our processes are in line with emerging trends.
• Lead the Quality Assurance department and provide oversight for the associated quality processes (batch record review, product release, review/approval of change control, nonconformance investigations, CAPAs, complaint handling, approval of technical and validation documents, etc.).
• Develop and execute the on-the-shop-floor QA oversight program for operations activities.
• Inspire, mentor, and guide a team of Quality Assurance professionals, fostering a culture of accountability, continuous learning, and professional growth. Provide coaching, feedback, and performance evaluations to maximize individual and team potential.
• Lead compliance oversight of site operations to ensure adherence to all relevant GMP regulatory requirements (FDA, EMA, etc.), industry guidelines, and company/site policies and procedures.
• Support or lead the escalation of quality issues which have potential to impact the commercial product supply chain.
• Collaborate with cross-functional teams to continuously monitor product quality throughout the manufacturing lifecycle, from raw materials procurement to final product release.
• Provide guidance and support to departments on quality-related matters.
• Manage the resolution of unexpected, complex quality and compliance issues.
• Manage relationships with external regulatory agencies and auditors, leading inspections and audits as required.
• Partner with peers and Quality Heads at other J&J sites to ensure harmonization and alignment with J&J Quality Policies, Guidelines, Programs and Systems.
• Risk Management: Lead the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues.
• Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.
• Support the development of the Quality department budget in line with routine business planning cycles.

QUALIFICATIONS

Required:

• Bachelor’s degree in a scientific or engineering discipline.
• A minimum of 8 years’ experience working within the biological and/or pharmaceutical industry.
• A minimum of 5 years of people management experience in Quality.
• Strong knowledge of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, and ISO standards.
• Deep understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment.
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Empowered professional who can make well motivated pragmatic decisions on their own.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
• Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs.
• Demonstrated ability to drive change, lead cross-functional teams, and promote a culture of quality consciousness.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• The ability to work in a team environment and interact with all levels of the organization.

Preferred:

• Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.)

This job posting is anticipated to close on 10/20/2024. T he Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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)).

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
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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.
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

• Develop and implement a comprehensive quality assurance strategy, aligning it with the company’s objectives and regulatory guidelines. Stay up to date with industry best practices and ensure that our processes are in line with emerging trends.
• Lead the Quality Assurance department and provide oversight for the associated quality processes (batch record review, product release, review/approval of change control, nonconformance investigations, CAPAs, complaint handling, approval of technical and validation documents, etc.).
• Develop and execute the on-the-shop-floor QA oversight program for operations activities.
• Inspire, mentor, and guide a team of Quality Assurance professionals, fostering a culture of accountability, continuous learning, and professional growth. Provide coaching, feedback, and performance evaluations to maximize individual and team potential.
• Lead compliance oversight of site operations to ensure adherence to all relevant GMP regulatory requirements (FDA, EMA, etc.), industry guidelines, and company/site policies and procedures.
• Support or lead the escalation of quality issues which have potential to impact the commercial product supply chain.
• Collaborate with cross-functional teams to continuously monitor product quality throughout the manufacturing lifecycle, from raw materials procurement to final product release.
• Provide guidance and support to departments on quality-related matters.
• Manage the resolution of unexpected, complex quality and compliance issues.
• Manage relationships with external regulatory agencies and auditors, leading inspections and audits as required.
• Partner with peers and Quality Heads at other J&J sites to ensure harmonization and alignment with J&J Quality Policies, Guidelines, Programs and Systems.
• Risk Management: Lead the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues.
• Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.
• Support the development of the Quality department budget in line with routine business planning cycles