Quality Assurance Manager

Company & Role Description

Founded in 2002, Tanner Pharma Group is a specialty service provider in the biopharmaceutical industry focused on improving patient access to medicines on a global basis. Tanner Pharma offers its biopharmaceutical partners a portfolio of four distinct service offerings that span the product lifecycle from clinical development to commercialization. With its global headquarters in Charlotte, North Carolina and offices in the United Kingdom, Switzerland and Brazil, Tanner Pharma is in a phase of rapid growth.

The Quality Assurance (QA) Manager role is a key part of the organization in establishing and driving a culture of Quality and Compliance within TPG. With accountability for monitoring and ensuring internal compliance of the global Quality Management System (QMS) and the overall regulatory compliance of TPG GXP operations internally and externally, this role is fundamental to the expansion and growth of the business, in line with regulatory expectations whilst minimizing risk to product quality and patient safety.

Role Accountabilities

Expected Responsibilities for the Quality Assurance Manager are:

Competent Authority inspection readiness and delivery

• Ensure a state of inspection readiness is always achievable within the territories.
• Develop and maintain a systematic approach to inspection readiness and inspection management, which ensures inspection observations and improvement opportunities are implemented.
• Maintain necessary GxP licenses and authorizations.
• Ensure licenses and authorizations are kept up to date to reflect all activities undertaken by TPG affiliates and variations / renewals are undertaken in a timely manner.
• Act as the principle point of contact for CAs relating to inspections, licenses, and authorizations.

GXP Subcontractor / Service Provider Assurance Program

• Develop, implement, and maintain a risk-based approach to subcontractor / service provider assurance and ensure a “lifecycle” approach to GxP subcontractor and service provider assurance.
• Ensure GxP assurance activities are integrated with other business due diligence requirements.
• Develop annual external audit plans.
• Participate in the delivery of external audits.
• Manage and oversee contractor auditors used for delivery of external audits identified on the audit program.

Supplier and Customer Qualification

• Maintain and support the processes for supplier and customer qualification.
• Monitor relevant regulatory and competent authority websites, notifications, and communications relating to license suspensions, revocations, or cancelations that may impact the status of suppliers and customers within the TPG supply chain.

Internal audit / self-inspection program management and delivery

• Manage the self-inspection process for TPG GXP operations.
• Ensure self-inspection expectations within each of the affiliate offices are met and that self- inspection programs are communicated effectively within the business.
• Ensure outputs from self-inspection activities are formalized into process improvements.

Client, Supplier and Customer audit readiness and delivery

• Develop and implement processes and systems for the effective management of client, supplier, and customer audit and / or qualification expectations.
• Act as the principal point of contact for clients, suppliers, and customers relating to audits of TPG.

Other Responsibilities

• Act as QA representative on specific projects, providing guidance and advice where required.
• Work cross-functionally within Tanner Pharma to support other divisions as needed.

Desired Candidate Profile & Capabilities
Required:

• 3-5 years of professional experience in the pharmaceutical/healthcare industry in a Quality Assurance or similar role
• Practical knowledge of both GMP and GDP preferred; however, an emphasis on GDP is anticipated.
• Familiarization of Quality Risk Management principles and practical experience of its application

Soft skills:

• Goal Orientation: Energetically focus efforts on meeting goals, missions or objectives while managing time and priorities.  Works well with a team to achieve a common goal.
• Detail-Oriented : Ability to accomplish/complete tasks while demonstrating a thorough concern for all the areas involved, no matter how small.
• Multi-tasking: Ability to manage multiple responsibilities at once by focusing on one task while keeping track of others; the ability to juggle multiple priorities effectively.
• Critical Thinking: Able to think in an organized and rational manner in order to understand connections between ideas and/or facts.
• Personal Effectiveness:  Demonstrating initiative, self-confidence, resiliency, and a willingness to take responsibility for personal actions.

Compensation & Benefits

• Salary commensurate with experience
• Pension scheme (UK)
• Private health insurance
• Attractive performance incentive plan
• Vacation, Volunteer 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.

Check out www.tannerpharma.com to learn more about our company.

Candidates may be required to organize reference calls upon request. Confidentiality will be respected. Additionally, Pre-employment drug and background screening will be required.

Tanner Pharma Group is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Job Type: Full-time | Exempt
Job Types: Full-time, Permanent
Pay: £50,000.00-£70,000.00 per year

Benefits:

• Company events
• Company pension
• On-site parking
• Wellness programme

Schedule:

• 8 hour shift

Experience:

• Pharmaceutical: 3 years (required)
• Quality assurance: 3 years (required)
• Quality Risk Management: 2 years (preferred)

Apply Now

Work Location: Hybrid remote in Redbourn AL3 7QA