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Manager, Compliance Operations

Employer
Southern Research
Location
Birmingham, AL
Start date
Jan 25, 2023

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Job Details

Manager, Compliance Operations

General Summary

This position is responsible for the operational aspects of Compliance at Southern Research (SR). The role overseas a small Compliance Operations team that manages planning, implementing, monitoring and proactively improving activities to ensure SR satisfies applicable quality and regulatory requirements in a high quality, efficient manner.

Key Responsibilities

  • Establishes a streamlined and relevant set of policies and procedures for the organization that supports SR employees to operate in a manner that maintains high quality and adheres to applicable regulation
  • Proactively modifies SR policies, procedures and processes to maintain adherence to changes in regulation
  • Institutes and implements risk and compliance assessments and monitoring processes to ensure SR consistently operates in a high-quality manner and meets all applicable regulation
  • Establishes the SR compliance committee and associated structure, operating procedures and agenda
  • Establishes OKRs with the team. Supports the team to problem solve challenges and ensure progress towards goals. Run huddles, meetings to ensure planning and implementation of compliance and quality improvements
  • Establishes strong relationship with internal and external stakeholders to support SR's operations to meet a high level of compliance
  • Establishes a user centric set of training programs and supports SR employees to meet training requirements in a timely manner
  • Supports the expansion and growth of the quality assurance and compliance management team to have an effective compliance program for SR and its employees
  • Coaches and develops team members to support individual and team growth towards operational and compliance excellence. Support and encourage development of team in areas of growth, personal vision, and potential
  • Manage day to day activities, improvement projects and initiatives related to compliance operations and the team
  • Serves as a back up for the Export Control Specialist and supports activities related to Export Control as needed
  • Supports the Technology division in meeting IT security standards and regulation
  • Supports the HR division in meeting labor regulation
  • Supports the Scientific divisions with meeting GLP standards and other regulation and requirements
  • Effectively communicate with SR personnel, clients, subcontractors, regulatory investigators, and third-party organizations as needed
  • Supports VP of Operations to work efficiently, set and manage budget
  • Support the needs of Southern Research in areas of compliance and quality for current and future endeavors

Minimum Qualifications

  • Bachelor Degree (compliance, legal or science-related preferred)
  • Experience with federal regulation
  • Ability to work with or experience working with cross-functional teams
  • Previous training and quality, compliance related systems implementation experience
  • Ability to lead, motivate and manage staff
  • Ability to successfully implement quality, compliance related processes
  • Project management experience
  • Effective communication, verbally and in writing to internal and external customers with the ability to offer experienced guidance to executive staff and subcontractors
  • Excellent judgment and decision-making skills
  • Ability to work with leadership at the executive level
  • Resourceful, self learner, detail oriented with experience working with regulation and or compliance divisions

Work Environment & Conditions

This position involves working in an office setting and various laboratory settings.  This position also involves entering BSL2 or BSL3 laboratory environments which will involve specific safety training and required use of PPE.  Also, specific vaccinations may be required.

Certifications, Licenses & Registrations

Certification as a registered QA Professional in GLPs (RQAP-GLP) is preferred.


Company

MOVING SCIENCE. Our experts turn what couldn't be done into what we can't live without. By translating research into innovation, we act as catalysts that save lives and cultivate Birmingham's biotech scene. We are conduits between Science and Society. With precision, we transform ideas into discoveries. We see possibilities before they exist and activate scientific progress that is purposeful. We move science, because the promise of a brighter future moves us. We work with more than 150 industry and academic partners to drive scientific discoveries. From drug discovery to development, to carbon capture and environmental health sciences, every layer of our scientific and professional teams serve a fundamental role in moving science. We're making Birmingham the biotech hub of the southeast. Coming in 2024, our new biotech center will feature 60,000 sq. ft. of commercial wet labs, A/BSL-3 space and data science facilities. Our team will grow 125 scientific jobs and help shape the future of biotech in Alabama. We're investing in renovations of 40,000 sq. ft. of facilities including vivarium space and launching a new clinical diagnostics lab.

Company info
Website
Phone
(205) 581-2000
Location
2000 9th Avenue South
Birmingham
Alabama
35205
US

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