HireDiversity

Lancaster, PA, US

Regulatory Systems Team Leader-5260130118

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Regulatory Systems Team Leader based in Lancaster, PA.

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 anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.

The Regulatory Systems Team Leader will be responsible for managing the regulatory compliance and quality metrics group for site cGMP compliance at the Lancaster facility. They will also be responsible for assuring competitive compliance with current GMP enforcement, while aligning strategically with McNeil quality/compliance initiatives. This individual will provide compliance expertise to the Quality System process and ensures that Plant operations consistently meet the requirements of cGMP's. The Regulatory Systems Team Leadwill ensure that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards. This individual will engage site Senior Quality Management to appropriately prioritize and put compliance improvements in place. They will also prepare, coordinate and host internal/external audits (including FDA) for the plant and coordinate audit responses and follow-ups and will provide cGMP training opportunities for the site per SOP, manages the site Internal Auditing program, manages completion of all site Non-Conformance reports, CAPAs, and interactions with the site's third party GMP experts, manages the Site Quality Management Review Process and all metrics used in the presentation of that meeting.

The Regulatory Systems Team Leader will provide compliance consulting to the process, ensuring that site operations consistently meet the requirements of cGMP's. This individual will ensure that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards and will direct the site Quality Council meeting - maintain listing and coordination/facilitation of meetings. The Regulatory Systems Team Leader will engage upper Operation's Management to appropriately prioritize and put compliance improvements in place. This individual will be responsible for the preparation, coordination and hosting of internal/external audits (including FDA) for the site and will coordinate audit responses and follow-ups. They will offer provision of cGMP training opportunities for the site per SOP and will direct the site's Internal Auditing program as well as ongoing systems for Batch Record Review and Release. This individual will manage the site Quality metrics for non-conformances and CAPA tracking and will direct ongoing systems for supplier quality management.

The Regulatory Systems Team Leader will provide direction and mentoring to supervisory 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. This individual will ensure that performance appraisals are routinely conducted, with development and succession plans in place. They will also provide Compliance direction to the PRT as one of the pillars of the process during the daily and weekly meetings. This individual will mentor site leadership on cGMP interpretation, application and current enforcement and promote interdependent partnerships with McNeil sites and Central Compliance. This individual will perform other related duties as required.

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 in Science, Statistics, Chemistry, Microbiology, Biology, Natural Science or a related technical discipline is required. A minimum of 6 years of relevant Quality Systems and/or Compliance experience within the OTC, Pharmaceutical and/or Medical Device and Diagnosis industry is required. A minimum of 10 years of professional experience including at least 2 years of supervisory experience is required.

Demonstrated experience in key leadership and decision making positions is required. The ability to determine the need for process interruption due to compliance related issues is required. Strong organizational skills and facilitation skills are required. Fluent knowledge of cGMP's and the ability to interpret them is required. It is required to have strong communication (verbal and written) and presentation skills. Strong skills in Interdependent Partnering and Influencing within a matrix environment are required. Project Management Experience is required.

Previous experience filing of field alerts and/or recalls would be a plus. Experience with Quality Records Management is a plus. Experience overseeing and updating Quality Site Master File is preferred. It is preferred to have experience performing annual product reviews. Experience with MS Office applications required. Extensive experience with technical writing is essential. Process Excellence tools, training and/or certification is preferred. Professional certification such as: CQE, RAPS, ASQ is a plus.

This position will be based in Lancaster, PA and may require up to 20% travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Relocation: Eligible
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