We are seeking a Head of Quality and Regulatory, reporting to the CEO.
The Head of Quality will be responsible for leading all facets of Quality, including, but not limited to the functional areas of Quality Assurance, Quality Control, Quality Management Systems, and Regulatory for all of Vibalogics’s multi-site operations. This will include oversight of all Quality Control (in house and outsourced) testing, Microbiology, Environmental Management testing, Quality Assurance review and approval, Validation review and approval, GMP training, Compliance activities, Product Release activities, and interactions with regulatory agencies. The Head of Quality leads Vibalogics’ quality organization, reporting to the CEO. The Head of Quality is responsible for leading the quality strategy and overseeing all aspects of the organization’s quality systems and processes.
This position is responsible for the overall meeting of business standards, achieving quality and compliance goals, and ensuring that Vibalogics is in full compliance with multi-jurisdictional government-mandated Quality and Regulatory policies and guidelines. The Head of Quality will represent Vibalogics to the FDA, EMA, and other health authorities.
Director Quality Systems, Director Quality operations, Director QC and Regulatory team.
Essential job functions:
- Collaborate with the Site and Department heads to ensure understanding and adherence to Quality Policies, Guidelines, Programs and Systems.
- Set standards for current Good Manufacturing Practice (cGMP) Quality for Vibalogics, by analyzing relevant regulatory authorities’ laws, standards, programs and activities in areas relevant to viral vector or viral vaccine manufacturing.
- Oversee testing and timely disposition of clinical and eventually commercial material to allow shipment to clients or their designees.
- Ensure compliance of the raw material and consumables vendors against the Vibalogics standards.
- Participate as a member of the Vibalogics Leadership Team and partner closely with the Chief Operations Officer and his/her team.
- Lead the Vibalogics organization with the goal of passing a Pre-Approval Inspection and to be able to deliver commercial supplies of viral products.
- Submit and maintain Site Master Files with regulatory authorities for Vibalogics commercial facilities.
- Establish key performance indicators for management of the Quality function and create alignment of KPI’s with all Vibalogics facilities.
- Ensure the team is providing timely, accurate and complete reports on performance at monthly site management reviews and at the Quality Council.
- Develop operating and capital expense budgets for the Quality functions. Ensure timelines are met and costs remain within the established budget.
- Work closely with the CTO and the Commercial function in the assessment of new opportunities and provide appropriate Quality and Regulatory input to prospective customers, including the demonstration of compliance through audit.
- Proactively develop and sustain strong relationships with top management of local/regional/national regulatory authorities, including design reviews prior to major capacity expansions as appropriate.
- Communicate and collaborate regularly and effectively with the Quality organization, as well as with internal stakeholders to facilitate successful customer management.
- Engage with existing customers to ensure clear communication of performance against goals and to maintain strong relationships.
- Evaluate the functional strengths and developmental areas in the Quality organization and focus on continuous improvement to ensure that standards are met.
- Other duties as required
- Outstanding leadership abilities with demonstrated analytical and critical thinking skills, combined with team management abilities to establish and maintain high-functioning teams
- Excellent troubleshooting skills with the ability to solve complex problems
- Visionary leadership skills and the ability to interact with all levels
- Proven leader, delegator and decision maker
- Strong financial acumen
- Executive presence with strong interpersonal and communication skills, verbal and written
Knowledge, skills and experience:
- Minimum of Bachelor’s degree in life sciences or a related field is required. Masters degree in a scientific related field or PhD is desired.
- Minimum of 15 years of hands on experience in a Quality role, ideally in a bacterial fermentation setting or biologics liquid parenteral aseptic-based operation with a minimum of 8-10+ years of experience in Quality leadership roles
- Deep knowledge and practices of clinical and commercial biologics site leadership, ideally including biologics manufacturing with strong science/technical background
- Service oriented mindset to support client needs without compromising compliance needs
- Ability to oversee projects to deliver high-quality work product to meet deadlines, cost, and quality goals
- Ability to work in a highly entrepreneurial environment, making informed but quick decisions, driving results through hands-on implementation.
- Prior experience in creating, building, implementing processes, and managing multiple sites
- Extensive knowledge of guidelines required by FDA, EMA, and other regulatory bodies
- Strong strategic skills, along with the ability and willingness to be hands on operationally
- Ability to plan forecast and manage a budget
- Excellent presentation and PR skills
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to travel up to 25% of the time, including international travel
- Ability to function in a rapidly changing environment & handle multiple priorities
- A flexible work schedule is required
- This role is based in Boxborough, MA
Vibalogics US, Inc. offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
To apply: please forward a resume to: Linda.email@example.com
Vibalogics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.