Senior Audit Mgr II Good Manufacturing Practices

Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.Job SummaryThis position is responsible for the conduct and preparation of reports of audits of the manufacturing, testing, packaging, labeling and distribution of commercial materials, clinical supplies and bulk pharmaceutical chemicals to determine the level of compliance with current Good Manufacturing Practice (cGMP) regulations, FDA Guidelines, W-R policy and applicable country and regional requirements. The position is also responsible for conducting audits of data contained in IND, NDA, and BLA submissions and international dossiers, to verify the accuracy and integrity of data. This position involves up to 30% travel, some of which may be international.Job ResponsibilitiesReview and accept internal and external audit assignments and conduct (and as assigned, lead) independent Global Compliance Auditing-Research cGMP audits, globally, of the most complex systems, procedures and controls employed in the manufacturing, testing, packaging and labeling of clinical dosage forms and active pharmaceutical ingredients to determine the level of compliance with cGMP regulations. Prepare for audit assignment by developing an audit plan/agenda in conjunction with any other team members. Audits are conducted in-house and at outside facilities. Schedule audits to maximize travel efficiencies and to meet Wyeth business needs and timelines.Conduct independent GCA-Research audits of the information contained in IND, NDA and BLA submissions, and international dossiers, to verify the accuracy of the submission. Usually leads rehearsal FDA PAI audits of facilities associated with regulatory submissions.Provide consultative support relative to interpretation of regulations and their implementation.Perform other duties as assigned; for example, participation on project teams, compliance policy and conformance standard review, and leading training sessions.Participate, in conjunction with other W-R personnel, in “Due Diligence” evaluations and audits of potential outside collaborations or joint ventures.Serve as a back-up to GCA-R-cGMP senior management.Perform audits of CTM Batch records, validation documents, SOPs and other regulatory documents to assure compliance with cGMP regulations.Prepare clear, concise reports of findings made during audits and present those findings to responsible management. Report results of the audit in the defined report format including categorization of the level of GMP Compliance Risk. Review and evaluate responses to audit reports to determine the adequacy of the proposed corrective action. Follow-up on the commitments made to verify the implementation of corrective measures.Maintain one’s skill-set and professional value through review of industry- /regulatory-related publications and training opportunities.Assist in regulatory agency site inspections regarding research activities. Assist contractors during regulatory agency inspections as requested.Basic QualificationsBA/BS degree required; degree in science/computer/engineering/medical field is preferred.Training in domestic and/or international GMP regulations is essential. Training in and/or exposure to audit processes are preferred.Training in Code of Federal Regulations is essential. Specifically, training in cGMP (21 CFR 210, 211, 600, 601, & 610), IND (21 CFR 312), and NDA (21 CFR 314) regulations along with the current FDA expectations in these areas is required. Formal audit training is desirable. Experience with foreign cGMP requirements is desirable.With a BA/BS degree, a minimum of fifteen (15) years experience in the pharmaceutical industry and/or FDA is required, of which ten (10) years should be in audit or regulatory. With an MS/MA degree, twelve (12) years experience is required. This experience must be in Quality Assurance, Quality Control, Drug Manufacturing (development or production), or Regulatory Affairs. Eight plus (8+) years audit experience is preferred. The incumbent must be able to write clear, concise reports. Experience with computers is essential. Strong interpersonal skills are required in order to interact with all levels of management.Relocation is not available for this position.Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.