QC Manager, Method Transfers and Validation

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Oct 06, 2020
Ref
4793960
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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

You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for overseeing the activities of the QC Method Transfer and Validation group which include review and approval of documents such as validation, qualification, verification and transfer protocols and reports, special study design and reports to support our quality programs. Your contribution to the laboratories' readiness for the routine testing of, but not limited to, Demo, Engineering, Clinical Trial Material (CTM), product/process validation and commercial batches will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control (QC) operations and instrumentation will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. You will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Manage multiple projects and ongoing work activities of moderate complexity within the site typically involving cross-functional representatives.
  • Oversee and guide your team on continuous improvement tools such as standard work and visual management.
  • Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports.
  • Collaborate with site functional areas and customers to support site goals, objectives and timelines.
  • Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.
  • Address and resolve any potential issues with regulatory impact.
  • Represent area of responsibility at meetings and in audits.
  • Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.
  • Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.
  • 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. Independently interprets and understands complex data and forms conclusions and next steps based on findings.
  • 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.
  • Provides interpretation of data and reports. Advises on more complex policy and procedures.
  • 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.
  • Use other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes
  • Contribute to site and Network Quality Operation related strategies and decisions


Qualifications

Must-Have
  • 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
  • 7 -8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • 2 -4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph. D in Science/related field
  • Demonstrated experience in Quality Control
  • Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques
  • 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.
  • Reasoning ability including strong analytical and problem solving abilities
  • Strong people management experience
  • Strong verbal and written communication skills
  • 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.

Nice-to-Have
  • Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.
  • Proficiency in Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Systems, Applications, and Products (SAP)


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: 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