Director, Quality Product Lead

Company: Pfizer Belgium
Location: Frankfort
Posted on: January 28, 2023

Job Description:

Pfizer Director, Quality Product Lead in Frankfort , Kentucky Why Patients Need YouEverything 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 AchieveAs the Quality Product Lead, you are a single point of contact, accountable to drive an end-to-end approach across the network for a group ofSterile Injectables and Biotech products. You assure consistency in achieving product quality and compliance across multiple manufacturing sites and global markets. You will provide coordination and leadership for cross-site quality and business processes and activities associated with products within the sterile injectable and Biotech portfolio to support supply targets. You ensure substantial risks are identified, escalated, and mitigated as appropriate.Your leadership skills and innovativeideas willdrive the growth of the Quality Assurance team at Pfizer. As an advisor and an expert, you will be able to build and leverage constructive relationships across theorganizationto achieve your division's goals and objectives. You will be entrusted with developing Pfizer's strategies for a portfolio of products and projects.Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.How You Will Achieve ItAct as a strategic Quality leader to drive alignment on network Product life cycles to ensure agility, compliance, supply, and customer service, by working with key stakeholders including Product Portfolio Leads, Brand Supply Leads, Site Quality Leads and Regulatory.Provide technical inputs to evaluate investigations, and product and process issues, including the ability to identify root cause and corrective and preventative actions and accountable to provide leadership to drive issues to timely resolution. Assure efficient and effective resolution.Escalate critical issues with potential quality, compliance or supply impact as needed.Drive resolution of critical product quality/compliance issues identified internally or by customers whether cross-site or internal to one site.Enable quality strategy and drive changes to support manufacturing product transfers across the network and to global markets as required.Liaise with Medical, Legal, Regulatory, Commercial and Operations as required to ensure brand integrity.Monitor and provide input for Global Product Performance and Compliance of key product performance metrics, including disposition cycle time, customer complaints and inspection readiness activities.Provide concurrence for significant investigations and associated corrective action and preventative action (CAPA) across the manufacturing network.Assess and facilitate product analytical plans, robustness and planned changes.Implement and Lead/Sponsor cross-site forums including Specification Review Committee, Global Change Review Board, Global Stability Forum, etc., as needed.Ensure drug substance (DS), drug product (DP), and component specification changes are managed by the Lead Site and are coordinated across sites for strategic projects.Participate in Regulatory strategy development, for example: supplements/variances, renewal and CMC Maintenance - Annual Reports and assure cross-site consistency of regulatory filings.Support product inspections from Regulatory Authorities, support conformance with regulatory filings, and support product recall activities by providing guidance and knowledge of regulatory requirements.Provide quality input to Operating Unit (OpU) Logistics and Supply strategy for sourcing key materials and components, and well as for the selection and qualification of internal and contract manufacture and testing for DS and DP.Recommend, facilitate, and support manufacturing and QA/QC process improvements if there is an impact across multiple sites.Participate in the Operating Units Quality and Compliance Forums.Identify and initiate Continuous Improvement projects.Identify product quality and compliance risks and drive mitigation strategies.Develop talent from different sites via opportunities to lead/participate in identified cross- site initiatives for assigned product.QualificationsMust-HaveBachelor's Degree in Engineering, Science, or related discipline with 10 years of experience in the Pharmaceutical industry with significant experience in biologics, vaccines, and/or biopharmaceuticals.Proven leadership skills and ability to involve several levels of an organization to successfully meet the objectives.Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority.Demonstrated skills in analyzing, organizing, and project management with a high sense of urgency.Demonstrated change agility to successfully manage a high degree of complexity and priorities.Strong knowledge of global cGMP quality and compliance requirements.Proven analytical skills capable of evaluating complex data to identify trends and signals.Excellent interpersonal and leadership skills including a demonstrated ability to positively influence and coach others, participate in teams at all levels of management and achieve results through others.Leadership and management of projects that require collaborative approaches, strong analytical skills, and a solid ability to understand business issues and processes.Must be fluent in English.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

• 5 years of robust site Quality management experience (preferred)Non-Standard Work Schedule, Travel, or Environment Requirements
  • Based on the global nature of this role travel is required (up to 20%).Work Location Assignment:FlexibleLast day to apply: 26 January 2023Relocation 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 ActPfizer 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.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.

Keywords: Pfizer Belgium, Chicago , Director, Quality Product Lead, Executive , Frankfort, Illinois