Quality Assurance Operations Manager

Employer
Arranta Bio
Location
Watertown, MA, United States
Posted
Sep 23, 2020
Ref
85503-308624
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

Quality Assurance Operations Manager will primarily be responsible for supporting late phase and commercial quality operations' activities. This highly motivated member of the Quality Unit will promote a culture of compliance throughout the organization through providing quality oversight of process and material life cycles. This Quality team member will be integral in building systems to support Quality Operations and in leading critical cross-functional collaboration.

ESSENTIAL JOB FUNCTIONS
  • Hire and develop new department personnel including providing training relevant to Quality Assurance Operations responsibilities and career growth
  • Actively participate in fostering a positive, collaborative work culture
  • Ensuring adherence to cGMPs across the organization
  • Manage raw material release, product batch record review, lot disposition, and the review of process validation protocols and reports
  • Lead investigation activities including deviations, CAPAs, complaints
  • Foster and develop intra- and inter-departmental relationships
  • Provide support for internal and external audits including report generation
  • Participate in developing project plans
  • Evaluate and mitigate program risk and escalate quality issues as needed
  • Provide Quality Assurance input and oversight for clinical and commercial projects, including technical transfers and the stability program
  • Support Quality Management Reviews
  • Other duties as assigned


Experience and Skills

  • B.S. degree in science or a life science-related field of study
  • 8+ years of experience in Quality Assurance in GMP environment, preferably with a technical background
  • Experience with management of direct reports
  • Strong knowledge of FDA, ICH, and EU GxP Regulations and Guidelines
  • Experience with ensuring alignment with relevant guidance and regulations
  • Involvement in risk assessment
  • Management of major and critical investigations, complaints, and CAPAs
  • Involvement in continuous improvement initiatives
  • Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
  • Proficiency in Microsoft Office suite applications
  • Effectively manages cross-functional communication
  • Multitasks, strategically and tactically in a fast-paced work environment
  • Strong organizational skills; able to prioritize and manage through complex processes/projects
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Detail-oriented and highly motivated with excellent written and verbal communication skills required.
  • Ability to work independently and stay on task in a fast-paced environment
  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.


PHYSICAL DEMANDS
  • Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing - writing,
  • Ability to lift and carry 10 pounds
  • Travel < 10%
  • This is an office-based position that may require some non-standard working hours including early morning or later evening teleconferences on weekdays and weekends to support global prospective and current clients.