Why Patients Need You 

The 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, raw materials, validation, and stability. 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 cGXP 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.

What You Will Achieve 

The individual should be able to demonstrate the following:

• Has sufficiently broad depth of knowledge of cGXPs 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 cGXPs for the commercial and clinical environment.

• Acts as SME for own department to support hosted site audits/inspections. 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.

• Implements unique approaches to problem solving. Independently manages increased levels of risk.

• 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.

• 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.

• 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.

Individual should have knowledge of US, EU, and ROW cGXP; 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).

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 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

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.

• Experienced and knowledgeable with laboratory practices, analytical testing and use of analytical equipment: i.e. PCR, ELISA, endotoxin as well as other immunobiological assays.

• Greater than 3 years of Quality Control experience and familiarity with Gene Therapy are preferred

• Previous leadership experience is preferred

• Experience supporting Board of Health inspections and successful interactions with inspectors 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

This role is primarily 2nd shift hours: 3:00-11:30PM

Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.

Limited travel for the position; no more than 15% traveling.

Other Job Details:

• Last Date to Apply for Job: April 3rd, 2023

• Relocation Assistance Eligible

• Work Location: Onsite

Relocation assistance may be available based on business needs and/or eligibility.