Current Job Openings

Senior Vice President Quality Assurance & Regulatory Compliance

Senior Vice President Quality Assurance & Regulatory Compliance

Job Mission: Responsible for all Quality Assurance and Regulatory Affairs activities for Tanner Pharma Group globally. Through strong interaction at a senior management level within Tanner Pharma and major biopharmaceutical companies, this is an ideal role for a candidate seeking an executive leadership role in a fast-paced and entrepreneurial company dedicated to improving lives by increasing access to medicines around the world.

Reports to:
President Tanner Pharma Group

Scope of Supervision: Tanner Pharma Quality Team

Number of Direct Reports: 4

Key Responsibilities:

Leadership and Management

  • Provide Quality leadership and subject matter expertise (SME) in Quality Assurance and Regulatory
    Affairs as part of the senior management and leadership team.
  • Instill a “Quality Culture” within the organizational leadership team and ensure the cascade of a
    Quality Culture down through the organization.
  • Develop and implement the Quality organization for TPG including the recruitment and development of
    key Quality roles with Operations, Compliance and Quality systems.
  • Oversee and manage QA & RA employees at all current affiliate sites in the US, UK, Ireland, and
    Switzerland, as well as in regions of future global expansion.
  • Develop and deliver a Quality Management System that supports all GXP operations globally, including an extensive network of approved subcontractors.

Operational Responsibilities:

  • Ensure QA & RA team members are appropriately integrated into all relevant leadership team
    discussions, company projects, and GXP business activities
  • Support with correspondence with regulatory bodies and competent authorities globally within the
    territories TPG operate.
  • Oversee the maintenance of all TPG licenses and authorizations in all affiliates globally relating to
    GXP operations and ensure all inspections against those licenses and authorizations have successful
    outcomes.
  • Support commercial divisions with the evaluation of new or alternative project and service solutions,
    ensuring regulations in new markets are understood, considered, and followed.
  • Oversee TPG pharmacovigilance requirements for adverse event training, documentation, reporting, and
    reconciliation in partnership with pharma partners.
  • Act as the QA & RA SME for all internal business CAPEX projects impacting GXP operations and
    activities.
  • Act as the QA & RA SME for all internal IT projects impacting GXP operations and activities, ensuring
    compliance with the expectations for IT system validation.
  • Develop and lead the Quality Management Review activities within all affiliates of the business and
    ensure senior management have visibility and input to global management review meetings.
  • Lead and maintain Tanner’s Quality risk management system to ensure risks are adequately identified,
    assessed and as appropriate controlled in accordance with current GXP expectations.
  • Lead the optimization of all QA & RA processes and establish metrics and key performance indicators
    for the Quality Management System.
  • Oversee TPG’s compliance program to ensures all subcontractors, suppliers, and vendors within the
    supply chain are appropriately assessed and qualified in accordance with the level of risk they
    present.
  • Act as Responsible Person / Designated Representative as necessary on licenses or authorizations held in the region(s) within which the role is based. Ensure all global authorizations / licenses name
    appropriate individuals as RPs and DRs and other formal / legally accountable roles.

This job might be for you if you consider yourself to be:

  • Team Oriented: Ability to integrate with the organizational Core Values, culture and team climate
  • Detail oriented: Ability to focus on the details, yet understand the overall direction
  • Self-Motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it.
  • Results Driven: The ability to focus on the desired result of one’s own or one’s unit’s work, setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
  • Collaborative: Ability to work well across teams to accomplish goals.
  • Communicative and Organized: Ability to create and provide clear direction. Process-oriented and follow a standard method to accomplish tasks.

You should meet the following criteria to apply:

  • Strong leader that is able to manage, align, and motivate teams globally and is willing to spend time
    developing and coaching QA & RA team members.
  • Solution-oriented collaborator that is able work with the commercial and technical operations teams to deliver the QA & RA objectives while supporting business growth.
  • Highly organized and adept at multi-tasking and working in a fast-paced and entrepreneurial
    environment
  • A finisher that can hold the QA & RA team accountable for following through on commitments and doing so in a timely manner
  • A good listener willing to understand the TPG business and incorporate differing perspectives, then
    comfortably and confidently make decisions and provide guidance
  • Masters Qualification or higher (or equivalent) in a Life Sciences discipline; Chemistry,
    Biochemistry, Pharmacy, Pharmacology, Biology, Microbiology, etc.
  • Minimum of 15 years of professional experience in the pharmaceutical industry in Quality Assurance or Regulatory Compliance focused roles
  • Extensive work experience covering GDP and GMP at European, US, and Global level; previous experience as an RP within GDP or a QP within GMP, acting on an MIA/ MIA(IMP) would be desirable
  • Expert knowledge of and experience with Quality Management Systems, including IT solutions for QMS
  • Experience working with regulatory authorities such as MHRA, FDA, EMA, Swissmedic or other
    Experience conducting audits of subcontractors and managing audits from third parties, including
    regulatory authorities
  • High attention to detail and a high standard for quality work products
  • Fluency in written and spoken English; Spanish and/or German language skills desirable
  • Self-motivated with a passion for learning and ability to recognize when something needs to be done
  • Strong, clear, and concise communicator both internally and externally with pharma partners or
    regulatory authorities
  • Authorization to work in the US or UK
  • International travel estimated at up to 20%

Compensation & Benefits

  • Salary commensurate with experience
  • Pension scheme
  • Private health insurance
  • Attractive performance incentive plan with profit sharing
  • Vacation and paid sick leave

Tanner Pharma Group’s Core Values: Everything we do at Tanner Pharma Group is dictated by our values. We take them very seriously, and we’re proud of this unwavering commitment.

  • ·Determined and Tenacious
    We persevere and are proactive in the pursuit of our vision and have the courage to tackle even the most difficult challenges. We have the resolve to always go the distance.
  • Resourceful and Creative
    We rely on, draw inspiration from and leverage our collective expertise and experience to conceptualize new ideas and apply smart thinking to solve problems and deliver success. We believe the status quo can always be improved upon.
  • Responsive and Caring
    We react quickly and efficiently to the needs and questions of our people, partners and patients, knowing that time is always of the essence and they are depending on us. We care about each other and the projects and programs entrusted to us.

Candidates may be required to organize reference calls with recent managers. Confidentiality will be respected.

Tanner Pharma Group is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of race, religion or belief, color, sex, age, marital status, pregnancy and maternity, family status, sexual orientation, gender identity, gender expression, national origin, disability or military obligation.

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