Site Head of Quality Assurance

Employer
Arranta Bio
Location
Watertown, MA, United States
Posted
Sep 23, 2020
Ref
85503-303334
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
ABOUT US

Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.

WHO ARE WE

Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.

Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.

We embrace our challenges as opportunities.

We are empowered to think and act.

We never settle; we strive to improve through purposeful creativity.

We build aligned teams who learn, grow, and deliver.

We are committed to building strong relationships.

Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today!

JOB SUMMARY

The Site Head of Quality Assurance will oversee all aspects of QA for the Watertown Manufacturing Plant and be responsible for the development and execution of risk-based, compliant, quality systems to support clinical and commercial manufacturing operations. She/he will build and manage the QA department and collaborate cross-functionally with Manufacturing, Supply Chain, Facilities & Engineering, Process and Analytical Development to ensure cGMP compliance and establish a quality culture. The Site Head of QA will be a strong partner with customers to ensure that project and delivery timelines and expectations for product quality and GMP compliance are met.

ESSENTIAL JOB FUNCTIONS
  • Build the Quality Assurance team, defining the organization's structure as well as managing a highly capable team of quality professionals with a clear vision to install and maintain quality processes, systems and relationships to drive best in class performance.
  • Quality Operations including lot disposition, audits, and deviation management
  • Quality Systems including document management, change control, CAPA and training
  • Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
  • Coordinates and executes periodic Quality Management Reviews and trend analysis of all aspects of cGMP operations.
  • Analyzes regulatory authorities' programs, guidance documents and activities in areas relevant to testing of biological products and advises organization of potential actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
  • Manage audits and inspections by clients, FDA and other regulatory agencies
  • Work with clients, external suppliers and contract labs to ensure compliance and quality, including management of audits and quality agreements
  • Identify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements
  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
  • Ensures the company is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.
  • Support client projects to ensure delivery and quality expectations are met or exceeded.


Experience and Skills

  • BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a quality position within the biological and/or pharmaceutical industry.
  • 10+ years in a management/leadership role(s)
  • Excellent working knowledge and experience with the practical implementation of FDA and EMA regulations and guidelines in cGMP manufacturing operation
  • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
  • Exceptional oral and written communication skills to all organization levels as well as clients and vendors
  • Extensive experience with managing regulatory inspections and client audits
  • Strong organizational skills; able to prioritize and manage through complex processes/projects
  • Ability to define problems, collect data, and draw valid conclusions
  • Experience in both startup/early phase and commercial GMP manufacturing organizations
  • Extensive experience with writing and managing investigations and risk assessments
  • Ability to write reports, business correspondence and SOPs
  • Ability to be hands-on and detail orientated
  • Must be able to analyze and interpret business periodicals, common scientific, professional and technical journals, governmental regulations and legal documents
  • Very proficient in MS Office application suite as well GMP electronic applications for training, document management, and QMS.

PHYSICAL DEMANDS
  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing - writing,
  • Travel 10%.
  • This role is based in Watertown, MA.


BENEFITS

Arranta Bio is an Equal Opportunity Employer.