Director, Site Quality

Description

The Director, Site Quality is responsible for the quality oversight and inspection readiness of the ongoing operation of Phlow's development, manufacturing, and warehousing resources at the Petersburg campus. This role serves as the system owner for quality tools and technologies and develops processes to ensure that quality operations in Petersburg follow applicable cGXP requirements, in a fast-paced environment. This individual collaborates with cross-functional teams and third party contracted resources to ensure excellence in quality oversight and operational execution for all Phlow products. This role will partner with Operations and MS&T leaders in Petersburg and participate in site Tier meetings daily.

Requirements

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work closely and partner with the network of manufacturing, development and quality partners and has accountability for Phlow's interest in the quality and compliance aspect of these partnerships. Update management regarding status of deliverables and identify critical activities/risks to ensure compliance.
• Ensure all development, manufacturing and warehousing operations comply to all State BOP and FDA cGMP requirements, including maintaining the site in a state of inspection readiness.
• Responsible for the review and disposition of starting materials, packing materials, intermediate and finished products for use or release as appropriate.
• Responsible for review of all associated quality operations documentation needed to support disposition including CAPA, Change Controls, Deviations and Batch Records.
• Responsible for calculating and compiling Key Performance Indicators and communicating any trends to management on a monthly basis.
• Ensure that appropriate compliance activities are maintained during operation to support cGMP compliance (calibration, validation, environmental monitoring, pest control).
• Review and approve Validation documents, plans, protocols, and reports used in support of Petersburg site activities to ensure compliance to regulatory requirements and company standards.
• Attend onsite visits to contractors as well as equipment manufacturers to support validation activities.
• Support supplier/vendor qualification audit and inspection management.
• Support any customer/vendor compliance audit/inspections as required.
• Ensure Phlow is prepared for all compliance inspections and support the on-site inspections as required.
• Contribute to the creation and implementation of quality operations strategies for assigned projects and programs.
• Contribute to the review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.

Experience & Qualifications:

• 15+ years of relevant experience in GxP, Quality Operations positions in a Biotech or Pharmaceutical industry, preferably in API Manufacturing.
• Understanding of GxP Regulations and Regulatory requirements required for Pharmaceutical productions, of Active Pharmaceutical Ingredients and sterile finished doses.
• Understanding of quality systems including document management, CAPA, deviation, Change Control and training. Super user or Admin training in an EDMS/QMS/LMS system is required.
• Experience with auto diagnostic or delivery medical devices a plus.
• Experience in commissioning, qualification and validation of new production sites and equipment.
• Experience in defining, qualifying and implementing enterprise level workflows, systems, and controls for computer systems.
• Must be proficient in MS TEAMS, MS SharePoint, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro.
• Demonstrated organizational skills, strong verbal and written communication skills, attention to detail.
• Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred
• Ability to work in a cross-functional team environment with changing timelines and priorities required.
• Ability to travel to support supplier/vendor relationships and audit programs.

Education & Certifications

• Bachelor's degree in related Life Sciences discipline.

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.