Pfizer
Pharmaceuticals
QualityOversightandComplianceDirector
“Quality Oversight and Compliance Director at Pfizer. Skills: Quality Oversight, Compliance, Regulatory Affairs, Drug Development Processes, Risk Management, Problem Solving. Developing and maintaining Quality Plans. Ensuring inspection and audit readiness”
What You'll Achieve.
Broadening and hastening patient access to Pfizer's medicines and vaccines; Ensuring that our commitment to excellence and integrity remains steadfast; Ensuring data and process quality; Ensuring that quality is built-in to enable consistent compliance; Providing optimal balance of compliance and business need; Timely completion of remediation plans; Meeting evolving business needs and established deadlines; Enhancing health outcomes and the patient experience
Industry & Context.
Analytical and problem-solving skills; Making decisions in complex problems; Recommending innovative solutions; Supporting in solving issues impacting business units; Identifying procedural/compliance gaps and deviations; Identifying root cause; Establishing and monitoring appropriate remediation plans
What They're Looking For.
Must Have
Profound knowledge of drug development, license maintenance processes, regulatory codes, guidance, and technologies, Experience with standard tools of continuous improvement and quality investigations, including DMAIC, root cause analysis, interview techniques and human performance analysis, Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and provide consultation as a scientific/technical resource for assigned projects, Familiarity with systems and electronic technologies that support regulatory activities, Ability to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs and established deadlines, Ability to work effectively within or lead a team in a matrix structure, Ability to influence without authority, Proficiency in Microsoft Office, analytical and problem-solving skills, Excellent written and verbal communication skills
Nice to Have
A Master's degree (MA/MBA/MS) with over 12 years of experience or a Doctorate (PhD/PharmD/JD) with more than 9 years of experience, Proficiency in Lean and/or Six Sigma methodologies, Experience in engaging with the external regulatory and pharmaceutical environment, A solid understanding of the business and financial landscape, Strategic thinking and the ability to develop innovative solutions, Experience in risk management and quality oversight, Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity, Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
What You'll Do.
Developing and maintaining Quality Plans
Ensuring inspection and audit readiness
Providing quality oversight of process deviations
investigations and associated corrective and preventive actions
Driving compliance of pan-regulatory information and processes globally
Instilling a quality mindset by ensuring the quality and compliance of regulatory processes and product/license information
Identifying data trends and addressing associated process risks
Identifying and investigating procedural/compliance gaps and deviations
Establishing and monitoring appropriate remediation plans
Supporting and driving implementation of inspection readiness
audit preparedness and training compliance
Leading/co-leading highly complex projects
Identifying critical quality process parameters/KPIs
Providing oversight of existing and input to planned processes/systems/controls
Establishing mitigation and remediation plans
Driving the investigation
remediation and closeout of Quality Events and associated CAPAs
Driving and supporting inspection readiness activities
Providing remediation support for audit (or inspection) findings
Identifying opportunities for improvement of pan-regulatory data and business processes and procedures
Interpreting regulations and designing compliance programs
How You'll Work.
Team & Collaboration
Collaborating with Regulatory Process Business Process Owners (BPOs) and stakeholders; Influencing colleagues across the organization; Working effectively within or leading a team in a matrix structure; Leveraging relationships to meet the needs of various business units; Serving as an advisor and influencing management decisions; Supporting partner functions globally
Communication Scope
Excellent written and verbal communication skills; Ability to present and articulate issues for resolution; Communicating regularly with key stakeholders to ensure alignment
Process & Methodology
Developing and leading/co-leading highly complex projects, Creating mid-term plans that impact results and drive innovation, Driving highly complex projects to meet evolving business needs and established deadlines
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