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Sr. Associate, Documentation Management Control & Trainer

Employer
Inozyme Pharma
Location
Boston, MA
Start date
Aug 11, 2022

View more

Discipline
Regulatory, Research/Documentation
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
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Inozyme is looking to expand their Quality team with an experienced QA professional and manager providing leadership, compliance guidance and direction for introduction of new clinical molecular entities, review and approval of manufacturing batch records, ability to direct and weigh in on clinical quality issues, can direct and lead incident investigations, reviews and comments on regulatory documents and can author policy and procedure. This person should have recognized subject matter expertise in one or more of the following Quality Assurance areas:  cGMP compliance, Clinical (GCP) compliance, computer systems, validation, biopharmaceuticals manufacturing, and/or regulatory affairs.

The Director of Quality Assurance, reporting to the Vice President Quality and Compliance will lead and direct or may perform activities such as but not limited to internal audits, quality control data/reports review and approvals, oversight to document management and control, deviation, CAPA and change control review and approvals, development of and tracking of quality metrics, and review and approval of process and product validations, etc. This role will lead real‐time quality oversight of the assigned clinical trials and the reporting thereof. The individual will also play a leadership role within the quality team as well as be the quality representative of the clinical operations group. This role will aid to ensure conformance with international domestic and internal quality system standards including but not limited to 21 CFR part 210, 211, parts 600’s, 11 and 312, EMA, GCPs, USP, EUPh., and ICH E6.

This individual will also provide solid technical and organizational leadership to Quality programs and activities and provide leadership and value-added services to the company. They will partner cross functionally to deliver the highest quality services to internal and external teams. The incumbent must be a strategic thinker, excellent communicator and possess the ability to inspire and lead others to achieve the critical mission of this vital functional area.

Essential Duties and Responsibilities:

  • Leads and manages the review and approval of CRO, CDMO and CTL activities of the quality control and validation efforts
  • Review of SOPs, investigations, corrective actions, change controls, and regulatory commitments in order to ensure compliance with quality standards and production schedules
  • Leads professionals within clinical quality, quality assurance and document management and control.
  • Leads the quality oversight for assigned global clinical trials (phase 1-3) in close collaboration with the clinical study team
  • Will recruit, attract, hire and develop employees within the Quality Assurance department. Mentors, coach, and provides feedback for growth. Oversees the Performance Management process and takes necessary disciplinary actions.
  • Ensures awareness and compliance with GCP and cGMP regulatory authority regulations and requirements.
  • Defines deliverables for projects and efficiently utilizes resources in order to meet project goals and scheduled timelines.  
  • Ensures short term and long term strategies are in place for department success.
  • Reviews and approves departmental procedures, protocols and reports.
  • Represents the Quality department to internal teams as well as CMOs, CTLs and health authorities.
  • Produces in close collaboration with clinical study team GCP quality metrics allowing real‐time quality monitoring and reporting; conducts trend analyses of GCP quality system metrics(e.g. audit observations, deviations, CAPAs, GCP QA activities) for management reporting
  • Drives the investigation of study quality events and the definition of necessary corrective and preventive measures
  • Leads inspection readiness and inspection management activities
  • Plays a leading role in the continued growth of the quality and clinical quality team alongside the Vice President of Quality and Compliance, including quality strategy, infrastructure, vendor selection / management, team mentoring, and recruitment

Desired Skills & Experience:

  • Extensive knowledge of FDA/EMA regulatory requirements applicable to Good Clinical Practice, clinical trial quality management and Good Manufacturing Practices for biologics or pharmaceuticals.
  • Strong ability to communicate effectively to peers and all levels of the organization within and outside of department, and with external contacts.
  • Excellent organizational skills and analytical and problem solving abilities, strong verbal and writing skills and good interpersonal and leadership skills.
  • Possesses exceptional time management and multi-tasking abilities in order to meet commitments and deadlines.
  • Identifies potential compliance issues and opportunities for improvement to the product disposition system.  Implement process improvement to enhance compliance and improve manufacturing process.
  • Team player with the ability to work collaboratively with other functions gaining their cooperation in dealing with issues of compliance.
  • Rational persuasion particularly in the discussion with CMC and Clinical Operations.
  • High attention to detail and concerns to standards are required.
  • Critical thinking with the ability to read, analyze and interpret technical data.
  • Deductive reasoning with the ability to deal with abstract and concrete variables in situations where only limited standardization exists.
  • Demonstrated ability to make key decisions.  
  • Technical knowledge of clinical trials, quality and biopharmaceutical manufacturing.
  • Ability to lead, motivate and educate others on phase appropriate product quality processes and clinical quality aspects
  • Capable of building effective relationships with internal and external stakeholders
  • Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines

Education and Qualifications:

  • Minimally a Bachelor’s Degree in Life Sciences or equivalent experience. 7+ years of experience in a cGMP and GCP environment or a combination of graduate level degree and work experience.
  • 5+ Years prior management experience preferred.
  • Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics. Ability to create, use and interpret scientific tables, charts, and graphs.
  • In depth knowledge of cGMP regulations and audits.

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EEOC Statement:
To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job’s alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.

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