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Astellas Pharma Senior Compliance Specialist in Sanford, North Carolina

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Audentes is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

As part of the Astellas Gene Therapy Engineering & Facilities team, the Senior Compliance Specialist is responsible for delivering compliant methods, systems, and documentation in support of engineering and facilities services. Examples include implementing and upgrading systems used to manage facilities, lab, and process assets including their maintenance, calibration, spare parts, drawings, and turnover packages; ensuring the asset lifecycle management (ALM) procedures and administration support to facilities teams and contractors is effective and compliant; participating in quality and regulatory initiatives to ensure compliance with applicable regulations, standards, and corporate policies; and ensuring work conducted by project teams is compliant with internal and external policies and procedures. The role is primarily located in Sanford, NC.

Primary Responsibilities

  • Administer the Quality Management processes for the Engineering & Facilities team (change control, investigations, discrepancies, CAPA's), filing of records, updating applicable quality management systems, and maintaining relevant metrics as assigned.

  • Lead facilities and systems continuous audit readiness initiatives through period walk throughs and assessments with area owners, capturing deficiencies for remediations, and tracking assignments, resolutions, and relevant metrics.

  • Establish and manage internal controls for the asset lifecycle management program, including processes for verification of incoming parts used for repair and replacement that require drawing, specification, material certification, or performance verifications.

  • Support the sustained compliance of departmental training curriculums, facility self-assessments, drawing and documentation controls, personnel and vendor qualification file maintenance, vendor/supplier audits and qualifications, site programs relating to regulatory or statutory compliance, and maintaining relevant metrics.

  • Support audit readiness, facilitation, and response activities for the department.

  • Provides direction and training to vendors, facilities personnel, and service providers as required to ensure that Quality Assurance expectations are communicated and followed.

  • Provides direction, procedures, and training to the systems user community including team members, vendors, and service providers ensuring feedback channels are open and collaborative, and the visibility of systems tools and tips is maintained.

  • Track and trend systems activities on a periodic basis, providing compliance metrics for Management Reviews.

  • Create maintenance plans and assist with defining maintenance processes, driving improvements and achieving KPI targets.

  • Evaluate opportunities to maximize asset life by leverage predictive and conditioned based maintenance plans (ie. vibration analysis, water loop chemistry, thermography, motor performance).

  • Support breakdown investigations and process improvement changes to maximize asset performance.

  • Supports vendor qualification processes, vendor/supplier audits and qualifications, and maintaining relevant metrics.

  • Facilitate the addition of new assets in accordance with asset lifecycle management procedures and workflow with visibility via dashboards, status reports, & meeting minutes.

  • Participate in audit readiness, facilitation, and responses in support of site teams.

  • Lead change initiatives and continuous improvement efforts such as Lean Six Sigma/5S.

About you

Must Have/Required

  • BA/BS and 8+ years of experience in pharma, biotech or similar life science field that are governed by cGMP regulation, or 12+ years in a focused facilities functional oversight role within the same fields.

  • Expert knowledge of CMMS, EDMS, and QMS applications.

  • Expert understanding of cGMPs and safety as they relate to the performance of maintenance, repairs, and changes to equipment utilized in the manufacturing process of drug product.

  • Excellent technical writing skills including SOPs, maintenance procedures and routine reports.

  • Direct experience creating and presenting statistical data analysis.

  • Expertise interpreting technical documents such as blueprints, schematics, logic flow charts, operating and maintenance manuals.

  • Excellent oral and written communications skills. A history of effectively presenting before management.

  • Occasionally required to stand up to 6 hours a day. While performing the duties of this job, the employee is frequently required to reach with hands and arms, stand; walk; talk or hear; and use hands to finger, handle, feel or operate objects, tools, or controls. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl, and lift 50 lbs.

  • Advanced experience with office and project software.

  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Preferred Qualifications

  • Lean Six Sigma experience, demonstrated by successful completion of a major improvement project.

  • Previous experience with a facility start-up.

  • Supervision of employees, contractors, and vendors.

  • Pharmaceutical, Biotech or Life Sciences experience.

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

Category Facilities, Utilities & Maintenance

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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