Compliance Manager

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

Arranta Bio seeks a Compliance Manager who brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for enthusiastic, and innovative individuals with a good understanding of upstream and downstream tech transfer biomanufacturing principles.

ESSENTIAL JOB FUNCTIONS

• Develop internal controls and policies designed to ensure that all compliance needs are met
• Work closely with department managers to review all departmental policies for compliance issues
• Accountable for ensuring full quality and regulatory compliance of the Arranta Bio Watertown facility, through maintenance & monitoring of Manufacturing GMP operations.
• Work as a liaison between manufacturing and Quality Operation and relevant Management systems.
• Serve as a resource for Tech Transfer activities · The ability to lead and train manufacturing teams to review manufacturing batch records, testing data, SOPs, Deviations, Change Requests, and Corrective and Preventative Action (CAPA) reports).
• Assist with Tech Transfer and Manufacturing Risk Assessment and Mitigation evaluation activities.
• Responsible for reviewing qualification and re-qualification of manufacturing related equipment and facility as the operations representative
• Guides functional team to complete protocols, reports and SOPs and have the knowledge base to review and authorize documents as the manufacturing representative in the absence of Senior Management
• Communicates to all functional area managers and supervisor Quality related initiatives and actions.
• Must be familiar with many GMP-related aspects and systems like:
• Non-Conformance Management
• Quality Risk Management
• Document and Data Governance
• Monitoring and Quality Reports
• Must have the ability to challenge and make recommendations
• Escalate compliance concerns to senior management in a timely manner
• The ability to review and approve Pre and Post implementation Major change controls as the manufacturing representative
• The ability to work as the functional area approver and reviewer · Maintain CAPA databases and Investigations and prepare trend reports
• The ability to follow-up on CAPA completion timelines pertaining to deviation, OOS, EM and audits
• Review and approve Validation and Qualification Protocols and reports including Analytical method transfers as the functional area representative
• Work in conjunction with senior management to establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
• Ensure high levels of communication with team, support resources and management regarding issue identification and resolution
• Evaluate functional strengths and developmental areas a team with the ability to focused on continuous improvement as it relates to compliance
• Other duties as assigned

Experience and Skills

• B.S. and/or M.S. in Biology, Biochemistry, Chemistry, Engineering, or related field
• 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
• 5+ years in a Manufacturing/Operations in a cGMP environment is required
• Experience in technical upstream and downstream, clinical, and commercial process execution preferred.
• Ability to lead investigations when needed by leveraging six sigma tools
• Ability to work by influencing peers and their reports and gain their cooperation.
• Ability to see the “big picture” while being capable of driving detailed, tactical execution.
• A high sense of urgency and a commitment to delivering results is essential.

PHYSICAL DEMANDS

• 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 occasionally, drive a motor vehicle.
• Communicate using telephone and e-mail.
• Work Environment This will be an office-based position that will require some non-standard working hours including early morning or later evening teleconferences to support global prospective and current clients