JOB SUMMARY

Quality Assurance Operations Associate Director will primarily be responsible for supporting clinical 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, QA-On-the-Floor and the review/approval of Quality Events
• Lead investigation activities including deviations, CAPAs, complaints
• Foster and develop intra- and inter-departmental relationships
• Provide support for internal and external audits
• 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
• Hire, recruit, coach, and train employees within the QA operations group.
• Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources.
• Set expectations, provide feedback and coaching, and take necessary action to ensure appropriate performance and goal attainment.
• Other duties as assigned

Required Experience:

• B.S. degree in science or a life science-related field of study
• 7 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%

MEDICAL REQUIREMENTS

COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation

ABOUT US

Arranta Bio is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. Arranta Bio’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives. Arranta Bio continues to expand capacity and development and manufacturing services across multiple sites with technology platforms designed to meet the evolving demands of our clients and partners.

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

Arranta Bio is an Equal Opportunity Employer.

BENEFITS

• Phone reimbursement policy for qualified individuals
• Free parking
• Highly competitive healthcare with many plan options:

• Medical (HMO/PPO/EPO)
• Dental
• vision
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Up to 10 weeks of 100% paid maternity leave
• 2 weeks of 100% paid paternity, domestic partner, & adoption leave
• Educational assistance program
• 401k (traditional and Roth offered) with 100% match on first 5% deferred.
• A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• Employee Referral program
• Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)
From: Arranta Bio