Mgr QA, Change Control and Validation

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Oct 06, 2020
Ref
4793959
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

This position will support the Pfizer Sanford, NC Quality Operations department by managing colleagues to perform Quality Operations activities associated with clinical and/or commercial product manufacturing. The QA Validation and Change Management Manager will primarily lead the QA operations functions associated with:
  • Change control and commitment change management systems,
  • Site compliance network member functions associated with site & global changes and regulatory notifications
  • Review and approval of site documentation including but not limited to, cleaning/process/equipment/laboratory validation, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing


Key responsibilities are as following: Colleagues objective setting, conducting one on one meetings with Colleagues, provides guidance/coaching, assisting with colleague development planning, and completing performance reviews; performing Quality approval/release of cGMP documentation/equipment/processes; plans and executes highly complex projects; identifies continuous improvements and leads the implementation; and interfaces with and represents the Quality Operations in cross-departmental/cross-site/cross-network meetings/summits. The QA Validation and Change Management Manager will report to the Site Quality Operations Director and will be a member of the Site Quality Leadership Team.

Eligible candidates should be able to demonstrate the following:
  • Has sufficiently broad depth of knowledge of cGMPs and own functional area to be a key contributor
  • Can generate and interpret metrics to support continuous improvement of quality and the business. Can promote and implement new processes and programs for quality improvement and business efficiencies. (e.g. leading yellow-belt or RFT activities).
  • Contributes to the interpretation of cGMPs for the commercial and clinical environment.
  • Acts as SME for own department to support network projects. Interfaces with other parts of the organization such as Vaccines Research Unit and Analytical Research and Development and serves as technical SME for Quality Operations in these interactions. 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.
  • Leads teams to make quality discussions, independently makes decisions based on sound judgement regarding complex quality and technical issues, and uses breadth of knowledge to contribute to broader strategies and decisions. Independently able to resolve complex issues. Represents Quality Operations in limited duration teams, cross-departmental/cross-site/cross-network meetings/summits.
  • Reviews trending reports and influences /agrees actions with key stakeholders.
  • Provide guidance/coaching to colleagues. Capable of determining colleague training requirements for setting curricula and assisting with colleague development planning.
  • Independently interprets and understands complex data and forms conclusions and next steps based on findings.
  • Implements unique approaches to problem solving. Independently manages increased levels of risk.
  • Provides interpretation of data and reports. Advises on more complex policy and procedures.
  • Makes decisions that may impact project progression and timelines.
  • Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas. May lead and approve complex investigation. Coach/mentor other colleagues with investigations.
  • Collaborates/independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
  • Anticipates issues and elevates them to appropriate senior management attention immediately.
  • Able to assess internal and external compliance with applicable regulations and provides suggestions on resolution of non-compliance.
  • Seeks mentorship from experts and proactively seeks opportunities to learn and improve.
  • Can influence and negotiate with multiple business lines. Interacts constructively and shares experience of quality approaches with other groups developing key partnerships and actively sharing knowledge and expertise within multidisciplinary teams within SpecBio in the importance of regulatory compliance.
  • Can set priorities for self and team for delivering on critical activities that have high business impact.
  • 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.
  • Established interpersonal skills (negotiation, managing conflict) to influence team.
  • Project management skills; understands the importance of and is capable of conducting stakeholder management
  • Capable and experienced excellent decision maker who includes global Pfizer impact awareness on future quality and compliance thinking as apart of decisions
  • Works well in the ambiguous space; independently can solve ambiguous personnel, business and technical issues/problems/conflicts
  • Uses other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes
  • Contributes to site and Network Quality Operation related strategies and decisions
  • Capable of metric setting, tracking, trending, evaluating, and drawing conclusions from for improvements and actions, and reporting for the Quality Operations, site, and/or Network
  • 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 Office™ 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); Systems, Applications, and Products (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
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.


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 5% required travel.

Other Job Details:
  • Last Date to Apply for Job: 20 October, 2020
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus


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.

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.

Quality Assurance and Control