Biopharma Quality Lead (outsourcing position) in Bucuresti

Enabling the Commercial Business and Biopharma Operations to manage risk and ensure quality is the purpose of Pfizer’s Biopharma Quality (BQ) organization. This purpose accompanies a bold aspiration, to set the industry standard in commercial quality and be the third pillar of Quality for Pfizer.The BQ organization provide Quality Consulting and Quality Oversight to over 20,000 commercial colleagues across pharmacovigilance, data privacy and promotional practices, this includes:Effective management of current and emerging commercial compliance riskOperationalizing global policies and procedures related to commercial qualityMonitoring quality across commercial activities and ensuring audit & inspection readinessIdentification and management of quality eventsEstablishing an integrated approach for quality improvement & optimized customer quality experienceROLE SUMMARYThe BQ Lead is accountable for the flawless execution of BQ services to enable Pfizer’s local biopharmaceuticals business to manage risk and ensure quality.The BQ Lead is the first and single point of contact for market(s) on all relevant commercial quality related matters. The BQ Lead is a subject-matter expert that enables Biopharma colleagues to implement and execute commercial activities embedding quality and risk mitigations whilst identifying emerging risks. BQ Lead drives a quality culture in accountable market(s), enabling commercial activities to be compliant and audit and inspection ready, responding to commercial quality queries through the provision of quality consulting, representing BQ during local audits whilst facilitating local governance processes and oversight & remediation activities.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.ROLE RESPONSIBILITIES Accountable for:Quality Consulting Act as single point of contact and subject-matter expert on commercial quality for Biopharma colleagues for their accountable marketsEnable 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 guidanceMonitor 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 requirementsDrive BQ transition to ‘Big Q’ through end-to-end BQ support establishement, communication to market stakeholders, follow up on feedback received and resolution of any issues identifiedDrive adoption of new BQ customer engagement/support models e.g., self-serviceDrive a culture of quality and complianceRespond to commercial quality queries and coordinate with SMEs when neededEmbed, advise and support commercial customers with the implementation of BQ policies, procedures and guidanceProvide design guidance for commercial programs to optimize the risk and benefit balanceLead and facilitate local committee approvals and other such meetings required for the provision of BQ servicesCollaborate with other BQ Leads to implement BQ Lead accountabilities across the markets or regional / global programs as neededEnsure quality thresholds (e.g. training compliance) are met across assigned markets and / or programsCapture and leverage data / metrics (i.e. program activity & cost data, vendor performance data, etc.)Oversight, Audit Readiness and Issue RemediationLead in-market audit readiness activities in collaboration with Audit Readiness and Quality Oversight (ARQO) TeamCollaborate 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 inspectionsProvide country leadership insight in state of control, risks and gaps through quality oversight results, quality events and learnings from audit readiness activitiesRepresent 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 ExcellenceAssess, 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 vendorsEnsure that vendors not complying with BQ requirements are identified, and define applicable CAPAs.BQ TrainingDrive awareness and upskilling of key customers e.g., Program Owners, Tool Owners, vendors, approvers, marketers, and field force colleagues to increase understanding of BQ policies and processes and enhance quality & complianceDeliver training and BQ awareness to commercial colleagues and contractors (as needed)Drive training completionEnsure training audience list kept up to date and shared with Training Strategy and Curriculum LeadShare feedback on training requirements, assets, process and communication effectiveness with Training Strategy and Curriculum Lead.Stakeholder Engagement Partner and collaborate across internal Biopharma Operations stakeholders including BOPs, enablement teams, and Bold Moves Team to deliver strategic solutions in support of ongoing and new business requestsFacilitate collaboration with biopharma stakeholders and business partners (e.g., Legal, Digital, Safety, Medical, Privacy, Compliance) to ensure effective end-to-end support for commercial initiatives and large-scale priority projectsIn collaboration with other stakeholders provide guidance to help biopharma colleagues compliantly use emerging digital tools and channelsProvide commercial quality insights and share market reports with local stakeholdersCo-ordinate local market BQ communicationsEscalate appropriate risks and issues to Regional BQ Lead and local stakeholdersRepresent commercial quality in local meetings and forums in partnership with applicable Biopharma Operations colleaguesIdentify continuous improvement opportunities and share with BQ colleaguesSupporting the BQ Lead GroupOversee collection of market service demand forecasts for BQ servicesPromote collaboration across the BQ community and exchange best practices and thought leadership across marketsProvide input into the BQ operating plan (e.g., local volumes) in collaboration with the Regional BQ LeadSupport assigned local, regional and global BQ initiativesAccountable for local implementation of regional and global BQ initiatives and for assuring these will meet local business needsBASIC QUALIFICATIONS Bachelor's degree required3-5 years of relevant experience with a minimum of 2 years' experience in pharmaUnderstand the fundamentals of the pharmaceutical industry, regulatory requirements, and risk managementProven ability to influence without authority, a wide range of senior stakeholdersExperience of audits and inspectionsDemonstrated extensive experience of aligning senior stakeholders and facilitating conflictLocal operating experienceExperience of working across cultures and multiple time zonesDetail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basisUnderstand the fundamentals of drug safety and risk management (e.g. Adverse Event reporting) and / or data privacy processesTeam collaboration spirit, with strong ability to work as a single driver and contributorStrong written and oral communication skills with focus on issue understanding and resolutionLanguage skills: fluent in English and other language(s) if requiredPREFERRED QUALIFICATIONSStrong business acumenExperience in commercial operations, safety, compliance, sales, and marketingExperience of assigned market(s)Experience in BQ services and scopeProficient in common technical tools (e.g. Microsoft Office)Purpose - Breakthroughs that change patients' lives...At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents.Flexible Work Environment We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.Bus Dev & Strategic Planning