at J&J Family of Companies in Springfield, Illinois, United States
Job Description
Sr. Director Quality & Compliance – 2406186015W
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/ .
Johnson & Johnson is recruiting for a Sr. Director, Quality & Compliance, located in Irvine, CA, Jacksonville, FL or any other approved Johnson and Johnson site.
The Sr. Director, Quality & Compliance (Vision) is responsible for overall strategy, execution and oversight of quality management systems functions and regulatory compliance to achieve business objectives relative to regulatory outcomes and product quality.
Functional accountability for this role includes: Quality System Management, Management Review, Q&C Metrics, NC/CAPA management,
Document and Change Control, Records Management, IT Quality Systems, Quality Planning, Design Control, Risk Management, Internal/External Standards, Escalation/Field Actions, Training, and QA Analytics and Solutions, for JJV. This position is also responsible to maintain, and continuously improves these systems by monitoring the performance and health of systems through metrics and analytics.
Represent JJV as strategic leadership role as part of the Global Quality Systems Standards & Process Council. Provides strategic input into
Enterprise QMS initiatives. Interprets and integrates resulting Segment and Enterprise Policies and Standards into JJV global QMS operations
Accountable for compliance with regulations such as, but not limited to, FDA Quality system Regulation 21 CFR Parts 820; ISO 13485, FDA Combo Regulation 21 CFR Parts 4; Current Good Manufacturing Practice (CGMP) regulation 21 CFR 210/211, and international regulatory requirements (Japanese MHLW, Brazilian ANVISA).
Accountable for strategy as well as provides support for FDA and other governmental or ISO Notified Body inspections conducted at JJV locations, including pre- and post-inspection support, as requested. Serves as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
Where delegated, service as Management Representative and Legal Manufacturer Management Representative/Person Responsible for Regulatory Compliance (PRRC).
- Management Representatives appointed to represent a Legal Manufacturer will also serve as the Person Responsible for Regulatory Compliance (PRRC) (for businesses which market products in the European Union (EU)).
Maintains a leadership presence with government regulators and external professional organizations in order to monitor and influence QMS and regulatory issues. Interpret and integrate regulatory changes (FDA/ISO/ ANVISA/JPAL/JJVCAS, etc.) into worldwide JJV QMS procedures.
Promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Supports departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Ensures talent development processes are implemented and executed to maintain a healthy pipeline of quality & regulatory compliance talent for JJV.
Scope of this position includes: JJV franchise, manufacturing and R&D sites across the following business segments – Contact lenses, intraocular implantable lenses, Eye Health surgical equipment, contact lens solutions and eye drops, and disposable/ consumable devices. This accountability also includes global quality systems deployment, oversight and compliance as it relates to Regional QA and associated governmental agency compliance accountability.
Adheres to environmental policy, procedures, and supports department environmental objectives.
DUTIES & RESPONSIBILITIES
Leads and directs Quality System department, manages the development and performance of assigned staff. Ensures the department’s objectives and accomplishments meet the organization’s goals and strategic plan.
Ensures the proactive identification of quality and compliance risks and the corresponding improvement plans
Establishes strategy for quality and compliance across the business and ensures adequate resources to support global programs. Effectively partners with senior management to support audit readiness/preparation for risk mitigation and corrective and preventative actions and on-going process improvements.
Drives the development and deployment of innovative global policies, requirements, and strategies for quality systems.
Champions continuous improvement initiatives across the segment that incorporates risk management, process excellence and measurement systems to align business benefits with action and resource prioritization.
Provides leadership in establishing systems to support the Quality Systems vision. Accountable for business results within JJV
Accountable to JJV VP QA and JJVC Chair and JJSV President for quality and compliance results.
Ensures resources are available to support quality systems.
Performs other related duties as assigned by management.
Management Representative and Legal Manufacturer Management Representative/Person Responsible for Regulatory Compliance (PRRC). The below is in supplement to the associates primary Job Description.
Serve as the Person Responsible for Regulatory Compliance (PRRC) if appointed to represent a Legal Manufacturer which market products in the EU. These representatives, and the appointed Deputy PRRC, irrespective of other responsibilities, have responsibility and authority that assures:
+ The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.
+ The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
+ The post-market surveillance obligations are complied with in accordance with Article 10 of EU MDR.
+ The reporting obligations referred to in Articles 87 to 91 of EU MDR are fulfilled.
+ In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of EU MDR is issued.
+ Day-to-day management and completion of the activities above is the responsibility of the functional/organizational process owners executing activities on behalf of the PRRC. The PRRC maintains oversight for these activities through review of Quality Management System performance and outcomes through Quality System Management Review, Quality Review Board, and escalation of quality & compliance issues.
The PRRC shall suffer no disadvantage within the organization in relation to the proper fulfillment of their duties, per EU MDR Article 15 section 5 This is assured through assignment of organizational responsibilities as well as corporate policies and procedures including an independent Regulatory Compliance organization which provides oversight and assessment of compliance for the processes and activities listed above. PRRCs have ultimate responsibility to ensure the required tasks are executed to meet obligations; and that their job descriptions and business goals are in place to ensure they are not compromised.
Qualifications
+ University/Bachelor’s Degree or Equivalent in Science, Engineering or Business
+ Minimum experience (number of month/years and type of work experience beyond formal education) required for com
