Quality Assurance Manager

The Manager of Quality Assurance is responsible for planning, managing, and tracking quality documentation, and having quality oversight of the operation of Phlow’s Quality Management System.  This role serves as the system owner for quality tools and technologies and develops processes to ensure that quality operations are following applicable cGXP requirements, in a fast-paced environment.  This individual collaborates with cross-functional teams (RA, Operations, IT, MST, etc.) to bring excellence in quality oversight and operational execution all Phlow products.Requirements · Support the organization to apply relevant quality standards and establish appropriate quality assurance processes to ensure compliance to those standards.

Evaluate relevant changes to industry standards and practices to improve the organization's quality assurance systems.· Develop and deliver internal training on quality assurance requirements, processes, and procedures. Partner with Operations to mentor and train staff to perform activities in accordance with the established quality assurance systems.· Evaluate internal controls, communications, risk management and maintenance of documentation, such as Standard Operating Procedures (SOPs), to assess compliance with internal and external safety, quality, and regulatory standards.· Provide support in the management of controlled documents to include writing, formatting, uploading, maintenance, and document changes, while also maintaining physical and archived documents using industry standard document control, change control practices and information technology systems.

Assist with determining requirements for records retention, storage and disposal for business activities governed by the quality assurance systems.· Work with internal departments/business units to identify nonconformities and support developing appropriate remedies and corrective actions. Additionally, identify risks and support departments in developing preventive actions.· Lead cross-functional teams to evaluate process effectiveness and develop and implement process improvement.· Prepare, maintain, analyze, and present metrics related to quality assurance activities for management review. Support management in evaluating organizational performance against quality goals and assist in developing performance improvement plans. Assist with the implementation of any resultant action items.· Advise internal customers to support achieving organizational quality goals and objectives while ensuring compliance to organizational SOPs. · Responsible for the review and disposition of starting materials, packing materials, bulk 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.· 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 review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.· Manage all licensing requirements in compliance with FDA and state requirements.· Provide operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections.· Other duties as assigned.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.

· 10+ years of relevant experience in GxP, Quality Operations positions in a Biotech or Pharmaceutical industry· Understanding of GxP Regulations and Regulatory requirements required for pharmaceutical productions, Active Pharmaceutical Ingredients. · Understanding of quality systems including document management, CAPA, deviation, Change Control, and training.· Must be proficient in MS SharePoint, MS Office 360 (MS Word, MS Excel, MS PowerPoint), Adobe Acrobat Pro. · Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred.· Ability to travel to support supplier/vendor relationships and audit programs.

· Bachelor's degree in related Life Sciences discipline.

· Ability to work in a cross-functional team environment with changing timelines and priorities required.· Demonstrated organizational skills, strong verbal and written communication skills, attention to detail.· Exhibits the highest level of reasoned judgment, discretion, and integrity. Integrity is our defining characteristic at Phlow.· Collaborates with others to achieve shared objectives. At Phlow, we are focused on working together, accepting feedback, and making it about results.· Ability to thrive in a fast-moving, continuous learning environment; iterating and learning as a team.· Active listener with a curious and open mind· Steadfastly pursues excellence in execution.· Servant leader

· 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.This position may require up to 25% travel with occasional increase in travel demands based on business needs.