Pfizer Site Quality Operations Leader, McPherson in McPherson, Kansas

ROLE SUMMARY

The Site Quality Operations Leader is responsible for providing leadership in assuring that appropriate systems and processes are in place at McPherson to meet or exceed the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site or by approved vendors. This position has a dual reporting relationship, both to the McPherson Site Leader and to the Regional QO Leader for Sterile Injectables; and, will be a member of the McPherson Leadership Team.

ROLE RESPONSIBILITIES

  • Key focus areas and responsibilities for this position include: Overseeing all McPherson Quality Operations/Assurance functions and Site Quality Review Team (SQRT); Planning, implementing and achieving Site Quality Operations objectives consistent with Site Objectives and Global Quality Operations objectives; Providing leadership, development and direction to the Quality Operations/Assurance team; Interfacing with global regulatory agencies.

  • The Site Quality Operations Leader will lead, manage and develop a diverse team of talented and engaged technical professionals with the responsibility of providing comprehensive support and guidance to all operations at the McPherson site in assuring Pfizer's Quality Standards are met. The incumbent must be capable of interacting with diverse stakeholders in different levels of the organization, from representatives of external site organizations such as Regulatory, GMS, PPD, PGRD, EPBU, OpEx, and Center Quality as well as all internal McPherson customers. This position will: 1) identify and resolve quality, process, and GMP problems; 2) manage overall process in evaluating site compliance to PQSs and implement appropriate actions; 3) manage the overall assurance and disposition of products produced in McPherson or by approved vendors; 4) approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications; 5) review key quality and regulatory documentation and implement appropriate actions, 6) lead and engage the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance 7) coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues; 8) develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and discussions; 9) develop the annual financial operating plan for the department, such as direct expense and staffing budgets with continued assurance of cost improvements; 10) manage the financial performance of the department and support both department and site Cost Improvement Projects (CIPs) to ensure goals are achieved or exceeded without compromising quality and compliance 11) provide strategic leadership to QO and KLT, 12) be a voice for change and continuous improvement.

QUALIFICATIONS

  • Bachelor's degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering. Master's degree preferred. At least 10 years directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience and education. At least five years of demonstrated success leading and developing professional colleagues and developing a staffing / organizational structure in a QO or manufacturing environment. It is desirable to have a demonstrated success as a Site QO Leader and an agent of change. Related experience in at least two different pharmaceutical manufacturing facilities preferable. Demonstrated record of successful interaction with senior management, regulatory agencies (e.g. FDA, EMA, ANVISA) and other internal and external auditing groups is essential.

TECHNICAL SKILLS REQUIREMENTS

  • Must have a successful track record of continuous improvement and development / implementation of best practices in Quality Operations or manufacturing. Thorough knowledge and understanding of the technical regulatory and commercial aspects of pharmaceutical products is required. Experience in Aseptic operations is highly desirable. Possess excellent verbal, written and interpersonal communication skills. Exceptional understanding of GMPs and demonstrated leadership, management, coaching, development and technical capabilities. Strong verbal, written, presentation and interpersonal communication skills. Proven ability to plan, implement, and achieve significant, complex goals and objectives. Demonstrated commitment to achieving objectives in a manner that is supportive of Pfizer Values and PGS mission elements. Desirable to have exposure to lean, Six Sigma and Transformation.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Other Job Details:

  • Last Date to Apply for Job: August 10, 2018Eligible for Relocation Package - YES

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.