Director - Regulatory Affairs Global CMC - Pfizer Inc - Collegeville

Job description
Role Description
This position reports to the Conformance Office (CO) Lead and is responsible for providing conformance oversight across Global Chemistry Manufacturing & Controls (GCMC) and providing guidance that creatively and appropriately balances business needs with compliance risk. This role is accountable for identifying, understanding, measuring, communicating, and mitigating conformance risks related to CMC regulatory processes and systems, such as CMC change management for Commercial and Investigational products, investigations, and commitments.

Responsibilities
*Apply knowledge of CMC processes and systems to provide both general and scenario-specific guidance across all levels of GCMC that appropriately balances conformance risk and business need.
*Design, develop, implement and analyze measures, metrics and data to appropriately characterize and communicate conformance risks across the GCMC organization, then develop and implement novel approaches to address gaps and mitigate risks.
*Drive, support and/or contribute to implementation of or revision to procedures, processes, systems, communication strategies, qualitative and quantitative process measures, and recommendations to drive continuous conformance improvement and ensure consistency, where appropriate, across the organization.
*Identify, document and track conformance issues, including procedural, process and/or system deviations, ensure appropriate investigations and corrective/preventive actions identified, utilizing the details to inform broader unmet conformance needs.
*Champion cross-functional and strategic initiatives, novel concepts and solutions to enhance and improve conformance.
*Consult across GCMC lines on their understanding and implementation of CMC processes, procedures and systems to identify inconsistencies, gaps, procedure/training needs, and ensure availability of appropriate tools to obtain conformance.
*Draw on broad knowledge of existing conformance concerns and targets to consult on GCMC and enterprise-wide projects to proactively mitigate conformance risks and, where possible, propose solutions that facilitate conformance achievement.
*Formulate conformance risk solutions novel to the pharmaceutical industry.
*Proactively assess the conformance needs and risks of GCMC and seek out novel approaches to address the needs and alleviate risks.
*Utilize procedure, system, and practical knowledge and expertise to assist in review and/or update of procedures, processes and training to both properly ensure user understanding and promote conformance.
*Determine procedural, process and system needs required to improve conformance, then develop and deliver approach, utilizing cross-functional teams as needed, to meet those needs.
*Initiate the creation of White Papers or position papers addressing current points of interest related to conformance.

Qualifications
EDUCATION AND EXPERIENCE:
*Bachelors or Masters level education in pharmaceutical-science or related discipline.
*10+ years within the pharmaceutical industry, ideally within Pharmaceutical Sciences, GMP Manufacturing, and/or Regulatory CMC.
*Conformance/Quality experience in pharmaceutical or other regulated industry is strongly desired.
*Strongly skilled in data manipulation and analysis (e.g., Excel, Access), SQL knowledge helpful.
*Lean and/or SixSigma experience helpful.
*Experience working cross-functionally on broad and strategic initiatives is a plus.
*Experience with CMC change management and CTD content is strongly desired.
*Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is a plus.

TECHNICAL SKILLS REQUIREMENTS:
*Demonstrated breadth of conformance knowledge and requirements is required along with several well-defined areas of particular expertise. Expert understanding of identifying and mitigating conformance risks within processes, procedures, and systems.
*For internal candidates, expert knowledge of supported tools, applications, processes and associated data; detailed knowledge of database logical structures is helpful.
*Able to build strong global and local networks across functions, lines and zones.
*Pharmaceutical or related industry experience required.
*Expert oral/written communication skills and presentation skills are required.
*Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.
*Ability to work independently is mandatory. Position receives minimal supervision and guidance and works independently on most projects.
*Experience with developing GMP, GLP, or GCP related SOPs.
*Prefer experience with CMC regulatory submissions, process developent and/or GMP manufacture of clinical and/or commercial products.

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