Compliance Manager

Company Information: At Wyeth, we discover, develop, manufacture and market innovative medicines that are leading the way to a healthier world. In a career at Wyeth, you will be an important part of a leading research and manufacturing organization. We currently have an opening in our Bulk Formulations Department for a Compliance Manager, at our Pearl River, NY facility (located on the Rockland County, NY/Bergen County, NJ border).


As Compliance Manager, Vaccine Formulation, you will be responsible for performing the functions associated with managing the Commitment (CMT)/CAPA Systems and Audit Programs. You will provide leadership to ensure timely closure and accuracy of commitments, review of corrective actions to ensure CAPA, manage self-audit programs of operational departments and participate in regulatory audits (internal/external). You will directly supervise a group of Compliance Coordinators. You will assure effective and efficient cross-functional team meetings. You will be responsible for the establishment of performance goals, and strict adherence to cGMPs. You will manage the MIR processes within the departments that comprise the Formulation Vaccine PPU. You will assure that MIRs and Commitments from MIRs are completed in compliance with SOPs and cGMPs. Through monitoring, coaching, training, and collaboration, you will make sure that MIRs and CMTs contain accurate technical information and are completed by the assigned due dates. You will verify that an adequate investigative approach is followed to reach the root cause for the deviation. You will investigate and review investigations. When necessary, you will elevate investigations concerns to your supervisor. You will develop and maintain systems for coordinating, tracking, and follow-up on all activities for MIRs. You will manage the Commitments assigned to investigation staff that supports the Formulation Vaccine PPU. You will participate in SOP review/approval process as required. You will participate in change control initiation and may present the change control for approval as required.

You must have a Bachelors degree, preferably in a technical/scientific discipline plus 5-7 years previous pharmaceutical industry experience. An advanced degree is a plus. You must have training in QA, QC, manufacturing processes, cGMPs, and relevant site SOP's. You must have 3-5 years of supervisory experience. You must have experience in problem solving, negotiations, presentation and supervision of a multi-layered organization. Experience in 3 or 4 of the following is required: Manufacturing Documentation Quality Systems (Manufacturing Investigations), QA/QC/Regulatory, Aseptic Processing, Technical Writing or Compliance.



Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.

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