Johnson & Johnson Careers
Las Piedras, Puerto Rico
Requisition ID: 3762180608
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Compliance Manager.
McNeil Consumer Healthcare markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products; BENADRYL®, ZYRTEC® and ZYRTEC®-D allergy medicines; IMODIUM® A-D anti-diarrheal; MOTRIN® IB; and SUDAFED® and SUDAFED PE® nasal decongestants.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Compliance Manager, you will:
• Ensure quality and compliance in all actions, and act in accordance to the principles expressed in Our Credo and the Quality Manual in all negotiations and activities within and outside the company, and assures these are met.
• Assure job descriptions are discussed with employees within the first five days of hiring, when the job descriptions have been revised or as needed, and submit the attendance sheet to the administrative assistant/coordinator of the area for processing.
• Provide compliance consulting to the process, ensuring that site operations consistently meet the requirements of current Good Manufacturing Practices (cGMP) and that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards.
• Manage site forums for continuous improvement (coordination/facilitation of meetings), engage upper management to appropriately prioritize and put compliance improvements in place, and provision of compliance training opportunities for the site as needed.
• Prepare, coordinate and host regulatory and corporate audits for the site. This includes, coordinating audit responses and follow-ups.
• Manages the site’s Internal Auditing Program, oversee the site’s Complaints Program and complaint investigations, escalate issues as required to Home Office compliance and tracks follow ups/resolution, and manage the site quality management review program including monitoring and interpretation of metrics and compliance risks.
• Lead the site’s Inspection Readiness Program for regulatory and pre-approval inspections.
• Ensure coordination with Home Office and publication of the annual schedule of internal audits.
• Ensure compliance involvement in the Process Review Team meetings, and participate/support the Escalation to Management process defined for United States Over-the-Counter.
• Provide direction and mentoring to supervisory and all level Quality professionals in meeting their tactical and strategic initiatives – focusing upon the support of ongoing base business, new product/process introductions and system improvements – in a compliant, cost-competitive manner. Ensure that performance appraisals are routinely conducted, with development and succession plans in place.
• Promote partnerships with United States Over-the-Counter sites and Home Office Compliance, and mentor site leadership on cGMP interpretation, application and current enforcement.
• Guarantee compliance with federal, state, and local regulations and with company policies and the Health, Safety and Environmental procedures. Promote and encourage employees to have commitment and alignment to the organization’s environmental policy.
• A minimum of a bachelor’s degree is required; Science is preferred.
• A minimum of eight (8) years of overall professional experience within the Consumer, Pharmaceutical or Medical Devices environment is required.
• Experience in Solid Dosage is preferred.
• Six (6) years of experience or more in Quality Systems and Compliance is required.
• At least two (2) years of supervisory experience is required.
• Knowledge of current Good Manufacturing Practices (cGMP) and the ability to interpret them are required.
• Demonstrated experience managing or supporting Board of Health inspections, including Prior-Approval inspections, directly in the inspection room is required.
• Project management experience is preferred.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required; SAP knowledge is preferred.
• Proficiency in English and Spanish (oral and written) is required.
• This position requires up to ten percent (10%) of travel. Ability to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Puerto Rico-Las Piedras
McNeil Healthcare LLC (7598)