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Associate Director of GMP Regulatory Compliance-2330130710
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting an Associate Director of GMP Regulatory Compliance, located in Las Piedras, Puerto Rico.
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D, MOTRIN® IB, PediaCare® upper respiratory medicines for infants and children, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J's Family of Companies or beyond, or whether this is your entry to the J&J's Family of Companies, we invite you to join us?. Creating the future of McNeil.
The Associate Director of GMP Regulatory Compliance provides leadership for, and oversight of, compliance posture and integration of regulatory and quality requirements within a McNeil site. Reports to, and works closely with the Director of Network Regulatory Compliance. Provides expert cGMP compliance support for key McNeil production activities regulated by FDA, EMEA, and other key applicable regulatory bodies. Works closely with, and provides oversight to, site quality, operations, and technical operations leaders to foster issue resolution and risk mitigation. Will also liaise with key quality and compliance partners, including Consumer Sector and J&J ERC functions, particularly in areas of interest regarding regulatory requirements and risks. Provides compliance oversight and proactively identifies and prioritizes compliance risks at assigned site. Assures compliance programs are implemented and maintained at the site. Identifies compliance signals that warrant attention. Supports deployment and implementation of the Quality Risk Management concepts to control risks and maintain vigilance. Works with business partners to mitigate compliance risks at the manufacturing site. Provides Compliance support to strategic projects/initiatives. Provides active compliance support in the product lifecycle management process (e.g. new product launch, significant changes, etc.). Supports site in preparing for Health Authority (HA) inspections (including Pre-Approval Inspections), assists sites during HA inspections and with any resulting compliance commitments. Monitors issue resolution progress and identifies emerging shortfalls and risks for management notification. Provides compliance advice to sites for critical issues and problem resolution. Supports the site with crisis management. Consults with, and supports, site leaders for the escalation and resolution of Quality and Compliance issues. Actively participates in site escalations. Reviews investigations with high regulatory potential, including those associated with FARs & recalls. Makes decisions regarding the applicability of cGMP and other Health Authority regulations to site. Support strategic alignment to J&J, Consumer Sector, and McNeil policies and standards. Provides proactive regulatory insight into new and upcoming regulations. Participates in the site product/management review forums (e.g., Quality Councils) to uphold effective risk identification and management, quality system evaluation, and appropriate response to issues. Partners with Compliance peers within the group, at McNeil sites, and with Consumer Sector and Enterprise regulatory functions, as appropriate, for strategic consistency and leveraging opportunities. Maintains personal professional development on new/upcoming requirements and technologies. All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelor’s Degree is required with a major in Biology, Chemistry, Pharmacy, Engineering or related science. Must have thorough technical knowledge of cGMPs and International regulatory requirements. At least eight (8) years of experience in Quality Assurance, Regulatory Affairs and/or Compliance with significant experience performing GMP audits/support of pharmaceutical manufacturing sites is required, preferably to include a broad range of product experiences. Must have strong knowledge of the pharmaceutical manufacturing, testing and reporting of regulatory requirements. Hands-on experience interacting with regulatory authorities (FDA) is necessary. Must have experience in communicating effectively to management regulatory requirements, issues and risks. Experience interpreting regulatory requirements in the light of current guidance and international regulatory body field activity is required. Experience managing multiple projects, prioritizing and adapting to business needs and understanding of business requirements is required. Prior experience in line management, training or mentoring is preferred. Proficiency in the use of Microsoft software applications such as: Word, Excel, Power Point and Outlook. Must be completely bilingual (English and Spanish) and possess excellent oral and written communication skills. This position will require up to 10% travel inside and outside of Puerto Rico.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI
Primary Location:North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Relocation: Eligible
Yes - Globally
Travel:Yes, 10 % of the Time
Job Function: Compliance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Associate Director of GMP Regulatory Compliance-2330130710
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting an Associate Director of GMP Regulatory Compliance, located in Las Piedras, Puerto Rico.
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D, MOTRIN® IB, PediaCare® upper respiratory medicines for infants and children, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J's Family of Companies or beyond, or whether this is your entry to the J&J's Family of Companies, we invite you to join us?. Creating the future of McNeil.
The Associate Director of GMP Regulatory Compliance provides leadership for, and oversight of, compliance posture and integration of regulatory and quality requirements within a McNeil site. Reports to, and works closely with the Director of Network Regulatory Compliance. Provides expert cGMP compliance support for key McNeil production activities regulated by FDA, EMEA, and other key applicable regulatory bodies. Works closely with, and provides oversight to, site quality, operations, and technical operations leaders to foster issue resolution and risk mitigation. Will also liaise with key quality and compliance partners, including Consumer Sector and J&J ERC functions, particularly in areas of interest regarding regulatory requirements and risks. Provides compliance oversight and proactively identifies and prioritizes compliance risks at assigned site. Assures compliance programs are implemented and maintained at the site. Identifies compliance signals that warrant attention. Supports deployment and implementation of the Quality Risk Management concepts to control risks and maintain vigilance. Works with business partners to mitigate compliance risks at the manufacturing site. Provides Compliance support to strategic projects/initiatives. Provides active compliance support in the product lifecycle management process (e.g. new product launch, significant changes, etc.). Supports site in preparing for Health Authority (HA) inspections (including Pre-Approval Inspections), assists sites during HA inspections and with any resulting compliance commitments. Monitors issue resolution progress and identifies emerging shortfalls and risks for management notification. Provides compliance advice to sites for critical issues and problem resolution. Supports the site with crisis management. Consults with, and supports, site leaders for the escalation and resolution of Quality and Compliance issues. Actively participates in site escalations. Reviews investigations with high regulatory potential, including those associated with FARs & recalls. Makes decisions regarding the applicability of cGMP and other Health Authority regulations to site. Support strategic alignment to J&J, Consumer Sector, and McNeil policies and standards. Provides proactive regulatory insight into new and upcoming regulations. Participates in the site product/management review forums (e.g., Quality Councils) to uphold effective risk identification and management, quality system evaluation, and appropriate response to issues. Partners with Compliance peers within the group, at McNeil sites, and with Consumer Sector and Enterprise regulatory functions, as appropriate, for strategic consistency and leveraging opportunities. Maintains personal professional development on new/upcoming requirements and technologies. All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelor’s Degree is required with a major in Biology, Chemistry, Pharmacy, Engineering or related science. Must have thorough technical knowledge of cGMPs and International regulatory requirements. At least eight (8) years of experience in Quality Assurance, Regulatory Affairs and/or Compliance with significant experience performing GMP audits/support of pharmaceutical manufacturing sites is required, preferably to include a broad range of product experiences. Must have strong knowledge of the pharmaceutical manufacturing, testing and reporting of regulatory requirements. Hands-on experience interacting with regulatory authorities (FDA) is necessary. Must have experience in communicating effectively to management regulatory requirements, issues and risks. Experience interpreting regulatory requirements in the light of current guidance and international regulatory body field activity is required. Experience managing multiple projects, prioritizing and adapting to business needs and understanding of business requirements is required. Prior experience in line management, training or mentoring is preferred. Proficiency in the use of Microsoft software applications such as: Word, Excel, Power Point and Outlook. Must be completely bilingual (English and Spanish) and possess excellent oral and written communication skills. This position will require up to 10% travel inside and outside of Puerto Rico.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI
Primary Location:North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Relocation: Eligible
Yes - Globally
Travel:Yes, 10 % of the Time
Job Function: Compliance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.