Employment Type: Permanent Position

Job Category: Quality Assurance

Department: Quality Assurance

Reports To (Position): Executive Director, Quality Assurance

Job Number: 308977

Position Overview:

The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Executive Director, Quality Assurance, this person will be responsible for providing leadership and ensuring GxP compliance and quality oversight for manufacturing operations. The applicant must have a strong working knowledge of phase-appropriate GMP requirements and will collaborate across the GMP team and support the filing of investigational new drug applications and BLA submissions and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerated clinical development.

Accountabilities and Responsibilities:

• Manages the operation of the GMP quality system, which involves on site 1-1 meetings with key business partners of the GMP organization and managing/providing quality guidance for onsite events that arise across all GMP activities and areas.
• Manages GMP QA Operations team. Considered a team leader, supporting and overseeing activities executed by the team. Trains, coaches, advises, and develops direct reports through onsite sessions.
• Acts as Quality and Compliance SME for manufacturing operations and may be asked to support other functional areas of the company as well. Makes quality decisions that may impact operations, ensuring appropriate escalation to management when needed.
• Participates in development, review, and approval of the Quality System and CGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
• Manages, reviews, and approves change controls, non-conformances, OOS, deviations, complaints, and related items; ensures investigations are thoroughly investigated and resolved.
• Manages, reviews, and approves manufacturing and QC records and other related records, resolution of all related issues and QA disposition of product batches. QA review and disposition of raw materials, buffers, other components, labels. QA review and approval of validation documentation for facilities, equipment, assays and processes.
• Performs internal audits of manufacturing operations and ensures audits are conducted on a timely basis; performs follow-up of audit CAPAs
• Performs vendor qualification assessments and audits; ensures assessments are conducted on a timely basis; performs follow-up of audit CAPAs
• Participates in regulatory inspections and other audits.
• Manages GMP training program for all staff engaged in CGMP activities at the manufacturing site
• Manages monitoring of Quality Systems, including tracking of KPIs, and Quality Risk Management program. Ensures escalation of quality issues to Executive Director, QA and Executive Team, as appropriate. Identifies risks and communicates gaps for quality and GMP processes/systems.
• Manages relationships and provides oversight of GMP activities conducted by third parties
• Works closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner
• Assists in identifying and implementing process improvement opportunities to existing systems.
• Perform other duties as required.

Essential Details:

Work Schedule

Full-time; days. The role will mostly involve standard working hours, but flexibility is required to attend meetings and calls. Weekend work possible to support production activities.

Travel

The role may include travel to meet vendors and attend conferences and meetings

Safety

Complies with all pertinent safety policies, rules and regulations.

Quality Responsibility

Development and maintenance of quality systems and GxP compliance for the business by ensuring that all QA team members comply with processes, procedures and instructions for all activities in which the team participates.

Scope

Works on complex problems where analysis of multiple factors and consideration of data must be interpreted for decisions to be made. Must be able to utilize past experience and established industry practices to temper decisions under consideration. Exercises judgment within a broad spectrum of situations which affect product, policy and procedures. This is a supportive role within the company and will provide responsibility for Quality Assurance. The role will involve working closely with the Executive Director, QA as well as operational teams across the company. 

Leadership Responsibility

The role will involve working closely with the Executive Director, QA as well as operational teams across the company.

Minimum Requirements:

Education

Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field

Experience

8+ years of extensive experience in establishing and maintaining compliant Pharmaceutical Quality Systems for the biotech/pharmaceutical industry with proven management experience.

Licenses or Certifications

Related certifications (ASQ, SQA, ISO) preferred

Knowledge, Skills, & Attributes

• Working knowledge of CGMP requirements for biologics manufacturing. Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture.
• Ability to interpret CGMP requirements. Ability to effectively develop and lead teams and work collaboratively in matrix organizations and team. Must have strong management and organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines. Excellent communication (verbal and written) skills required. Problem solving skill and ability to make quality decisions based on technical facts and sound risk assessments is required.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.

Working Environment

The majority of the work is performed in an office environment however, work is also performed in a lab environment; work may involve common hazards found in a lab environment. In some areas, gowning may be required.

Relocation Assistance: Yes