Quality Director Jobs

About The Position

Requirements

• Bachelor’s degree in Pharmacy, Engineering, or another related science field, with at least 8 years of experience in pharmaceutical or medical-device Quality Assurance roles with direct product-quality decision responsibility and/or experience in the pharmaceutical or medical-device industry; alternatively, a master’s degree with at least 7 years of experience, or a PhD with 5 or more years of experience.
• Proven success leading teams and cross-functional projects or initiatives.
• Demonstrated communication and influencing skills, including the ability to work effectively across functions and organizational levels and build culturally sensitive working relationships.
• Demonstrated experience managing a team, directly or indirectly.
• Demonstrated ability to manage complex quality and compliance activities for pharmaceutical products at a manufacturing plant or with a contractor.
• Investigation skills and knowledge of DMAIC, 6 Sigma, Yellow Belt, or Green Belt methods.
• Ability to manage multiple projects, prioritize work for self and others, and complete work effectively through teamwork.
• Demonstrated ability to resolve conflicts.
• Advanced computer skills with MS Office and enterprise systems such as SAP, QTS/QMS, Vault, PDM, Documentum, Minitab, and AI tools such as CoPilot Pro.
• Proficiency in written and spoken English.
• Strong technical writing, verbal and written communication, and presentation skills.
• Demonstrated DEI attitude.
• Demonstrated clinical and special-license know-how.
• Experience managing batch certification and importation.
• Initiative, proactivity, persistence, strong organization and planning skills, and a high sense of urgency.
• Detailed knowledge of the manufacture and packaging (primary and secondary) of drug substances, solid oral-dose pharmaceuticals, and/or aseptic or sterile pharmaceutical products.
• In-depth knowledge of quality-system regulations and demonstrated ability to evaluate and apply global GMPs to develop effective Manufacturing/QA/QC systems.
• Knowledge of major regulatory directives and guidelines, including dossier structure and variation guidelines.
• Leadership capability to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues’ work to achieve meaningful outcomes and business impact.
• Authorization to be employed in the United States by any employer; permanent U.S. work authorization is required. U.S. work visa sponsorship is not available.

Nice To Haves

• Knowledge of IMEx.
• Postgraduate science-based qualifications.
• Experience and personal leadership in virtual teams.
• Experience managing external suppliers or contractors.

Responsibilities

• Provide Quality leadership to cross-functional virtual site operating teams (VSOT) and virtual site leadership teams (VSLT), as appropriate.
• Lead and support the development, implementation, and maintenance of Quality Assurance and Quality Control systems for APIs, global pharmaceutical products, suppliers, and medical devices operated by contract partners, as applicable.
• Partner with colleagues to develop and negotiate Quality Agreements.
• Partner with Global Logistics and Network Services to maintain GDP oversight during the manufacture and shipping of medicinal products, as applicable.
• Drive development, implementation, and continuous improvement of Pfizer products, processes, and quality systems.
• Support GMP/GDP regulatory inspections at vendors and ensure appropriate Pfizer review and approval of responses to regulatory agencies, including tracking corrective and preventive actions.
• Provide Quality leadership for significant deviations or customer complaints at contractor or partner sites that may affect compliance status or require regulatory notifications.
• Ensure effective CAPA implementation and quality-system improvements based on remediation activities.
• Lead generation of QRT summaries, as applicable, and participate in relevant meetings.
• Lead quality risk-management activities and manage mitigation plans within CMOs and suppliers.
• Ensure on-time disposition of commercial products in line with agreed schedules and make Pfizer lot disposition decisions.
• Lead, develop, and support manager- and senior-manager-level colleagues in accordance with Pfizer PEX policies and procedures.
• Manage multiple complex projects and ongoing work, and manage people, technological, and financial resources, including resources outside direct authority.
• Communicate business priorities and issues effectively across departments and business lines, and collaborate with peers and colleagues to achieve business outcomes.
• Support ESOQ leadership on other tasks as required.
• If applicable, oversee external testing activities at contract testing organizations for release and stability testing.
• Manage 5–6 direct reports and review and approve colleague expenses while ensuring costs are managed within budget expectations.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a 20% target bonus.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.