Biopharma Quality Lead

Biopharma Quality enables the Commercial Business and Biopharma Operations to innovate and operate at lightspeed by providing consultancy, risk-based controls and oversight to embed quality in user-centric, end-to-end business processes.

The BQ organization provides Quality Consulting and Quality Oversight to over 20,000 commercial colleagues across pharmacovigilance, data privacy, and promotional practices, this includes:

- Standardizing quality processes to drive consistency and enable the business to move at lightspeed.
- Proactively addressing emerging regulatory and compliance risks
- Streamlining implementation and delivery of new and evolving processes
- Maximizing user experience and promoting self-service
- Building expertise and agility into the BQ workforce to create a “best place to work” environment.

ROLE SUMMARY

The BQ Lead is accountable for the flawless execution of BQ services to enable Pfizer’s local biopharmaceuticals business to manage risk and ensure quality.

This role is expected to maintain strong relationships with senior commercial stakeholders, as well as Legal, Digital, Safety, Medical, Privacy, Compliance, and other related stakeholders, in partnership with Biopharma Operations Partners (BOPs), in their accountable market(s). They play an important role in embedding good practices in Commercial whilst proactively driving awareness of the evolving BQ strategy and driving buy-in to changes.

The BQ Lead will be involved and share best practice across the BQ Lead community.

The BQ Lead will drive thought leadership and share best practice across the BQ Lead community, whilst shaping global continuous improvement initiatives.

ROLE RESPONSIBILITIES
- Enable commercial customers to design and execute commercial activities embedding compliance and quality requirements through design, development, approval, execution and close-out of in-scope commercial activities (e.g., programs, tools, privacy requirements where implemented eg, IRRs for GDPR markets)
- Ensure consistent quality standards and effectiveness measures across commercial activities in line with global quality plans and quality by design guidance.
- Monitor and impact assess changes to local regulations for in-scope quality areas in collaboration with relevant stakeholders (e.g., compliance, legal, safety, regulatory and digital)
- Proactively identify emerging local commercial quality risks and user experience requirements
- Demonstrate consultative partnership through end-to-end BQ support establishment, communication to market stakeholders, follow up on feedback received and resolution of any issues identified.
- Drive adoption of new BQ customer engagement/support models e.g., self-service
- Drive a culture of quality and compliance.
- Respond to commercial quality queries and coordinate with SMEs when needed.
- Embed, advise and support commercial customers with the implementation of BQ policies, procedures and guidance.
- Provide design guidance for commercial programs to optimize the risk and benefit balance.
- Lead and facilitate local committee approvals and other such meetings required for the provision of BQ services.
- Collaborate with other BQ Leads to implement BQ Lead accountabilities across the markets or regional / global programs as needed.
- Ensure quality thresholds (e.g., training compliance) are met across assigned markets and / or programs.
- Capture and leverage data / metrics (i.e., program activity & cost data, vendor performance data, etc.)

Oversight, Audit Readiness and Issue Remediation
- Lead in-market audit readiness activities in collaboration with Audit Readiness and Quality Oversight (ARQO) Team
- Collaborate with ARQO Team on quality events, audit findings and remediation (root cause analysis, Corrective and Preventive Action - CAPA- development) for assigned market(s)
- Execute, manage and monitor performance of assigned CAPAs required to address issues (e.g., quality events, audit findings) in collaboration with BQ ARQO team for assigned market(s)
- Upskill commercial colleagues (e.g., Program Owners) to fulfil their role during audits and inspections
- Provide country leadership insight in state of control, risks and gaps through quality oversight results, quality events and learnings from audit readiness activities.
- Represent Biopharma during audits, support inspections in accountable market(s) and provide input where required (e.g., audit report).
- Accountable for vendor audit management (logistics, document request fulfilment etc)

Vendor Excellence
- Assess, evaluate and maintain accurate performance data for vendors operating within accountable market(s)
- Assure BQ preferred vendor list meets critical business needs in accountable markets and drive adoption of usage of preferred vendors.
- Ensure that vendors not complying with BQ requirements are identified, and define applicable CAPAs.

BQ Training
- Drive awareness and upskilling of key customers e.g., Program Ow