Biopharma Quality Lead Walton-on-Thames, England
Pfizer
Full Time
Walton-on-Thames, England
47988 - 88632 GBP ANNUAL Today
Job description
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.
The BQ Lead is the first and 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.
The BQ Lead will drive thought leadership and share best practice across the BQ Lead community, whilst shaping global continuous improvement initiatives.
ROLE RESPONSIBILITIES
- Act as single point of contact and subject-matter expert on commercial quality for Biopharma colleagues for their accountable markets
- 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 Owners, Tool Owners, vendors, approvers, marketers, and field force colleagues to increase understanding of BQ policies and processes and enhance quality & compliance.
- Deliver training and BQ awareness to commercial colleagues and contractors (as needed)
- Drive training completion
- Ensure training audience list kept up to date and shared with Training Strategy and Curriculum Lead
- Share feedback on training requirements, assets, process and communication effectiveness with Training Strategy and Curriculum Lead
Supporting the BQ Lead Group
- Oversee collection of market service demand forecasts for BQ services
- Promote collaboration across the BQ community and exchange best practices and thought leadership across markets.
- Provide input into the BQ operating plan (e.g., local volumes) in collaboration with the Regional BQ Lead
- Support assigned local, regional and global BQ initiatives.
- Accountable for local implementation of regional and global BQ initiatives and for assuring these will meet local business needs
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 requests.
- Facilitate 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 projects
- In collaboration with other stakeholders provide guidance to help biopharma colleagues compliantly use emerging digital tools and channels
- Provide commercial quality insights and share market reports with local stakeholders.
- Co-ordinate local market BQ communications
- Escalate appropriate risks and issues to Regional BQ Lead and local stakeholders.
- Represent commercial quality in local meetings and forums in partnership with applicable Biopharma Operations colleagues.
- Identify continuous improvement opportunities and share with BQ colleagues.
Stakeholder Engagement
- Proactively engage with regional and global BQ community to exchange best practices and lessons learned and enhance collaboration across countries.
- Act as change agents to help build internal and external alignment during transformation.
Driving continuous process improvements
- Drawing upon best practice to identify new ways of working and drive continuous improvement.
- Proactively identify and drive implementation of local and above market opportunities to improve ways of working within BQ team and with stakeholders (involve BQ global team (corresponding Effectiveness Leads and ARQO), other functions as needed)
- Encourage and drive adoption of new technologies and ways of working to drive innovation and operating efficiencies (e.g., self-service)
- Continuously provide feedback on training assets, procedures, guidance and other such BQ materials to improve effectiveness and stakeholder experiences.
BASIC QUALIFICATIONS
- Bachelor's degree required.
- Relevant experience with a good understanding of Pharma
- Understand the fundamentals of the pharmaceutical industry, regulatory requirements, and risk management.
- Proven ability to influence without authority, a wide range of senior stakeholders.
- Experience of audits and inspections
- Demonstrated extensive experience of aligning senior stakeholders and facilitating conflict.
- Local operating experience
- Experience of working across cultures and multiple time zones
- Detail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basis.
- Understand the fundamentals of drug safety and risk management (e.g., Adverse Event reporting) and / or data privacy processes.
- Team collaboration spirit, with strong ability to work as a single driver and contributor.
- Strong written and oral communication skills with focus on issue understanding and resolution.
- Language skills: fluent in English
PREFERRED QUALIFICATIONS
- Strong business acumen
- Experience in commercial operations, safety, compliance, sales, and marketing
- Experience of assigned market(s)
- Experience in BQ services and scope
- Proficient in common technical tools (e.g. Microsoft Office)
ADDITIONAL REQUIREMENTS
Preferred location within 2-hour time difference of GMT
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.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
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.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Mkt & Sales/Commercial Bus
Pfizer
www.pfizer.com
New York, United States
Albert Bourla
$10+ billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
1849
