Manager, QC Bioanalytics

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

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 in the Bioanalytical team. 

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. 

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

• 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 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)

How You Will Achieve It

• 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 colleague's 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

Must-Have

• 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.

• Reasoning ability including strong analytical and problem solving abilities

• Strong people management experience

• Strong verbal and written communication skills

Nice-to-Have

• Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

•  Greater the 5 years of Quality Control experience and familiarity with Gene Therapy are preferred

• Previous leadership experience required, and experience leading people leaders is preferred

• Experience supporting Board of Health inspections and successful interactions with inspectors preferred Bachelor's Degree

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

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: January 26th, 2023

• Relocation Assistance Eligible

• Work Location: Onsite

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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