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Document Quality and Compliance Team Lead

2 months ago

Collegeville, United States Pfizer 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 activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.

As a Team Lead, you will be subject matter expert and leverage your knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the division. Your ability to interpret your division's strategy will establish business priorities that support and set long-term direction for the division. Your managerial skills will help us manage and lead people, technological and financial resources within the division.

How You Will Achieve It

Provides leadership, management and oversight for SQ DQC colleagues. Supervises staff ensuring they fully undertake their duties and responsibilities relating to document and data quality review activities which will potentially include Lightspeed1 programs/products and accelerated submissions.
Develops people, including recruitment, engagement, retention and career development strategies for the SQ DQC colleagues and works in concert with the Director Team Lead/Head of SQ DQC to define and implement succession plans.
Provides oversight and guidance to SQ DQC staff and manages ongoing analyses of data resulting from the quality reviews of regulatory submissions and Safety documents.
Develops and fosters effective relationships with key internal and external customers,stakeholders, and senior leadership to design and implement quality strategies for Lightspeed1 programs and accelerated submissions.
Supports the implementation and execution of the SQ quality framework across global WWS processes and deliverables.
Participates in strategic planning sessions and team meetings as a member of the SQ extended LT.
Leads and participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives, including strategies supporting accelerated advancement of products.
Ensures SQ DQC is responsive to customers/stakeholders and adequately meets their needs by providing timely quality support across the portfolio, potentially including Lightspeed1 products and accelerated submissions.
Participates in the investment and strategy decisions related to the technology enhancements.
In collaboration with Director Team lead, assists with developing processes for quality control activities and the resulting metrics focusing on compliance measures (internal & external), data quality and process related assessments. Shares results with customers providing them with continuous improvement suggestions/opportunities.
Serves as a lead quality expert for team members, customers, suppliers, and vendors, and provides advice and guidance to other SQ colleagues and customers/stakeholders as appropriate.
Serves as Subject Matter Expert (SME) of global regulatory requirements relative to pharmacovigilance and regulatory submission requirements.
Leads support activities for regulatory inspections, internal audits and/or strategic quality initiatives which may include requirements related to Lightspeed1 projects and/or high profile products.
Participates on special projects and senior management requests associated with safety compliance.
Serves as quality SME on training, knowledge sharing, technology or specific work processes, providing advice and guidance as appropriate.
Makes decisions regarding review of safety processes and/or documents that may affect projects, processes and/or product delivery, which may include Lightspeed1 or accelerated programs/products.
Collaborates effectively with Business Unit and Partner Lines, as well as external industry and professional organizations.
Maintains current knowledge of Pfizer policies, operations, worldwide regulations and guidelines that impact safety data management, reporting and pharmacovigilance.
Participates in the development and implementation of strategies for compliance/performance and process analytics, information delivery and corrective action implementation, especially for programs with Lightspeed designation.
Assists with quality reviews to ensure accuracy, consistency and completeness of documents deemed for regulatory submission in accordance with agreed upon timelines. Quality reviews will potentially include Lightspeed programs/products and accelerated submissions.
Champions, maintains and instills global perspective with a focus on strategy, promoting quality oversight, and Right First Time initiatives.
Leads DQC Team in the implementation and execution of the SQ quality framework across global WWS processes and deliverables.
Provides strategic and operational leadership for DQC delivery of services in collaboration with the Head of SQ-DQC and participates in strategic planning sessions and team meetings as a member of the SQ extended LT.
Leads project teams, task forces and/or working groups, within and across disciplines, to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives, including strategies supporting accelerated advancement of products.
Leads the investment and strategy decisions related to the technology enhancements.
In collaboration with Head of SQ DQC, develops/evolves processes for quality control activities and the resulting metrics focusing on compliance measures (internal & external), data quality and process related assessments. Shares results with customers providing them with continuous improvement suggestions/opportunities.
Leads special projects and senior management requests associated with safety compliance.
Maintains a comprehensive understanding of Pfizer policies, operations, worldwide regulations and guidelines that impact safety data management, reporting and pharmacovigilance.
Defines, develops and delivers strategies and operational plans for compliance/performance and process analytics, information delivery and corrective action implementation, especially for programs with Lightspeed designation.

Qualifications

Must-Have

BS degree (or equivalent) with 7+ years' experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
Experience in quality control and/or quality assurance within the pharmaceutical industry preferred.
Extensive knowledge of global safety regulations and guidelines, or equivalent.
Demonstrated strength in analytical skills and attention to detail.
Demonstrated strength in oral/written communication and interpersonal skills.
Demonstrated organizational/project management skills.
Ability to make decisions independently and resolve issues appropriately.
Demonstrated computer literacy, particularly in the use and management of relational databases.
Innovative and strategic thinking ability.
Previous management/leadership experience is required.
Leadership, project management, resource management, administrative, and technical capabilities.

Nice-to-Have

Master's degree preferably in a Scientific or technical degree and relevant pharmaceutical experience

Other Job Details:
 Last Date to Apply for Job: July 24th, 2024.
Work Location Assignment: Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control