Director Clinical Supply Operations

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 Ireland, Tanner Pharma is in a phase of rapid growth.

This position is responsible for the day to day operational management of the GMP labelling and packaging operations at Tanner. This will include but not be limited to, ensuring compliance with all regulatory processes and procedures associated with secondary GMP operations, receiving, storing, label production, packaging, distributing, returns processing and project management.

This role requires attention to details, the ability to interact with all levels of the organization, the desire to provide hands on coaching and mentoring of staff, ability to communicate both verbally and written, and collaborate with cross-functional groups.

Role Accountabilities

Expected Responsibilities for the Director Clinical Supply Operations are:

• Oversees all GxP activities related to clinical packaging and labelling, comparator supply, and distribution.
• Applies current Good Manufacturing Practice principles in all areas of responsibility.
• Develops and maintains packaging room schedules to identify timelines as to when jobs will be executed and assignment of appropriate personnel to each room.
• Oversees material specification and acquisition processes, label production and approval and randomization approval process.
• Coordinates activities between internal departments, clients, and suppliers.
• Develops specific short-term and long-range goals and programs as well as supporting budget requests and financial estimates.
• Manage all activities and all projects in conjunction with local change control procedures.
• Responsible for assuring that GMP and SOP guidelines are followed.
• Drives quality and productivity to meet client delivery requirements and financial commitments.
• Participates in daily reviews and Gemba walks to accurately report and communicate actions to attending departments.
• Assists with escalated issues and resolves any issues in conjunction with QA and Team Leaders.
• Works with Project Management to resolve any questions associated with manufacturing and packaging operations.
• Provides Feedback to Senior Management with any issues and concerns, and provides monthly reports on quality, safety, on-time performance, and productivity of the group.
• Develops staffing resource plans to ensure that client and business needs are met.

Desired Candidate Profile & Capabilities

Required:

• Bachelor of Science and 10+ years of related experience in food, chemical, cosmetics, or pharmaceutical packaging.
• More than 5 years of experience in clinical trials supply or 5 years of experience in FDA or EU GMP regulated environment
• Prior experience working within a clinical supply operations role, ideally for a small-to-midsized CDMO / Contract Packaging Organization (CPO).
• Experience leading a clinical trial packaging and labelling operation, working with multiple stakeholders across QA, Logistics, Supply Chain and Project Management.
• Strong understanding of GxP regulations
• Comfortable with shifting priorities, demands, and timelines
• Ability to effectively prioritise and execute tasks in a high-pressure environment.
• Experience leading and working lean operations.
• Must be fluent in English with excellent written and verbal communication skills.
• Must be located at our facility in Charlotte, North Carolina Preferred:
• Certifications for lean management, packaging, quality, supply chain, management, or pharmaceuticals helpful
• Experience in process validation or process engineering
• Understanding of Expanded Access Programs / Managed Access Programs.

Soft skills:

• Thoroughness: Ensuring that one’s work and information are complete and accurate; following up with others to ensure that agreements and commitments have been fulfilled.
• Adaptable: Able to be flexible and adjust to changing factors, conditions, or environments.
• Results Orientation: 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.
• Strategic Thinking: Ability to see the big picture, plan ahead, and put thought into action to the advantage of the business.
• Detail-Oriented: Ability to accomplish/complete tasks while demonstrating a thorough concern for all the areas involved, no matter how small.

Compensation & Benefits

• Salary commensurate with experience.
• 401K (US).
• Private health insurance.
• Attractive performance incentive plan.
• Vacation, Volunteer and paid sick leave
• Relocation expenses

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 http://www.tannerpharma.com to view our core values and 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

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