Sr Manager, QA Operations
Location:
Sanford , North Carolina
Posted:
November 17, 2017
Reference:
1869036075

ROLE SUMMARY The position will support the Pfizer Sanford, NC Quality Operations Department by performing Quality Assurance activities associated with clinical and commercial production of bulk drug substance conjugated vaccine products. Key responsibilities are performing Quality final authorization/approval/release of production documentation (batch records); plans and executes highly complex projects; suggests improvements and conducts continuous improvement activities; interfaces with and represents the Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits, and provides guidance/coaching to less experienced colleagues. The QA Operations Manager will report to the Site Quality Operations Director and will be a member of the Site Quality Leadership Team. The main areas of responsiliby for this role include: Ownership and oversight of the disposition/final batch release for the site. Ownership and oversight of the investigation system for the site. May lead and approve complex investigations. Ownership and oversight of the Risk management program for the site. Ownership and oversight of post-disposition activities for the site. Ownership and oversight of the microbial control strategy for the site. The individual should be able to demonstrate the following: Capable and experienced excellent decision maker and people leader who includes global Pfizer impact awareness on future quality and compliance thinking as a part of decisions. Capable of metric setting, tracking, trending, evaluating, and drawing conclusions for improvements for the Quality Operations department as the department head. Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas. Supports above site communication of critical issues and capable to manage communications at the appropriate level. Manage workload to meet established timelines. Leads and manages work for others. Proactively and independently applies departmental best practices to work assignments. Has sufficiently broad depth of knowledge of GXPs to be a key contributor and be able to lead continuous improvement to a process or improve business efficiencies. Works well in the ambiguous space; independently can solve ambiguous personnel, business and technical issues/problems/conflicts Acts as SME for department to support hosted site audits/inspections. Subject matter expertise in given work area and is able to review own work and work of less experienced colleagues or peers. As a recognized SME, independently review working instructions/global procedures for technical content across multiple subject areas, with reference to applicable GXPs and regulatory expectations make value-added comments. Interfaces with other parts of the organization such as Vaccines Research Unit and Analytical Research and Development as well as in the biotech network, to serve as technical SME for Quality Assurance. Recognized as a "go-to" person for a broader subject area. Routinely and competently works outside immediate subject area, supporting a wider range of customers of differing subject areas and locations. Independently able to resolve complex issues. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits. Prioritizes effectively: Delivers on critical activities that have an impact across work groups and therapeutic areas. Interacts constructively and shares experience of quality approaches with other groups developing key partnerships and actively sharing knowledge and expertise within multidisciplinary teams within the OpU in the importance of regulatory compliance. Influences colleagues from other departments by gathering and disseminating key information and experience. Able to recognize when a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly. Routinely demonstrate a good practice of technical exchange and open communication with team members. Participates in and may take a lead in decision making process. Team Involvement: Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team. Experience managing highly complex and/or high impact business systems or products from the Quality Organization perspective Proven excellent and consistently used leadership soft skills Individual should have knowledge of US, EU, and ROW cGXPs; Microsoft Officeâ„¢ applications specifically Word, Excel, PowerPoint, Access, and Project; Lean Six Sigma concepts; project management tools including stakeholder management; Quality Systems, and Quality Risk Management including risk assessments. Preferred experience with Laboratory Information Management System (LIMS), Global Quality Tracking System (TrackWiseTM application), and Enterprise Ressource Planning Applications (e.g., SAP) ROLE RESPONSIBILITIES Responsible for knowing, understanding, role modeling, and ensuring others follow the Pfizer's values and our OWNIT culture. Manages the tasks/activities associated with maintaining cGXP compliant Quality Control or Quality Assurance systems/areas. Responsible for colleagues objective setting, conducting one on one meetings with Colleagues, providing guidance/coaching, assisting with colleague development planning, and completing performance reviews Determines appropriate training curriculums for colleagues Responsible for review, approval and final authorization of cGXP documentation (e.g. data records, reports, protocols, batch records, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values. Manage a working area and manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines Responsible for participating in, leading, or providing guidance for investigations Serve on or leads cross functional teams to represent Quality Operations and facilitate communications and activities/projects between Quality Operations and site departments and/or Network. Interfaces with other parts of the organization such as Pfizer research and development groups and serves as technical SME for Quality Operations in these interactions. Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation. Plans and leads highly complex, high business impact projects to ensure their timely completion. QUALIFICATIONS 10 or greater years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Previous leadership experience preferred Experience with Board of Health inspections and interacting with inspectors preferred Demonstrated capability of making risk-based Quality decisions associated with batch disposition preferred PHYSICAL/MENTAL REQUIREMENTS Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Primarily standard work hours with some exceptions to meet business needs. Limited travel for the position; no more than 10% required travel. OTHER INFORMATION Relocation assistance eligible, but not a full relocation package 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. Last Date to Apply for Job: 24 November, 2017 This job is (Pfizer) (Exempt) (US/PR) Grade: 014 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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