HP Compliance Operations Manager

BoehringerPRD • Burlington, ON

13d • Hybrid

About The Position

Serve as a strategic business partner to core functions in creating awareness, understanding and acceptance of Legal & Compliance requirements to embed a culture of compliance into the company's daily operations. Develop and foster strong working relationships across the departments in the business to lead the organization in integrating and operationalizing compliance requirements. Take full ownership of local Operational Compliance responsibilities by leading the cross functional Human Pharmaceuticals (HP) organization in creating, optimizing and overseeing critical compliance related processes. Accountable as the lead reviewer/approver on various critical compliance processes, ensuring the highest standards are met. Is recognized as a compliance expert with extensive experience across multiple businesses and departments within the pharmaceutical industry. Provides leadership, mentoring and guidance to others and represent the Business functions (Marketing and Commercial) on the Company Compliance Steering Committee. Demonstrates a high level of adaptability and expertise with the ability to provide direct back up to the Company Compliance Officer on specific functional operational topics as needed. This job posting is for an existing vacant position.

Requirements

• A Bachelor’s degree or higher, with experience in compliance related activities preferred
• 5+ years professional experience, 3-5 years demonstrated experience in healthcare compliance within a Pharmaceutical or Medical Device company
• Experience in managing complexity and ambiguity well: able to develop and apply pragmatic solutions to complex legal, regulatory and industry best practice standards and requirements
• Strong attention to detail and excellent Project Management skills. Prefer accredited project management training
• Strong leadership and interpersonal skills to drive change; skills and ability to build strong relationships with peers and stakeholders and influence without authority
• Organized with systematic approach to prioritization and operational excellence.
• Has a demonstrated can-do attitude to find solutions with strong problem solving and issue resolution skills
• Able to work independently and deliver results with minimal supervision
• Computer skills (i.e. MS Office,Outlook, PowerPoint, Word, Excel)
• Ability to work collaboratively with internal and external customers
• Adapts to changing conditions and drives accountability and results

Nice To Haves

• Prefer accredited project management training

Responsibilities

• Be an early adopter of Compliance within the HP Canadian organization, lead the creation and optimization of critical compliance related cross functional department processes; drive operationalization and use in daily activities within business:
• Lead the HP organization wide strategy for development and implementation of compliance related controls, including Standard Operating Procedures, Frequently Asked Questions, process flows, decision trees, analytical frameworks and automated systems
• Work with departments to lead the implementation of the above and the deployment of live and web based training to employees, consultants and other third parties as applicable.
• Subject matter expert for compliance related workflows within the organization and first point of contact for all compliance related workflow questions
• Local Business functional representative for Global HP Compliance initiatives
• Information Governance Lead for the organization. Lead the development and optimization of information governance processes across the organization. Provide direction and consultation to all records retention coordinators within the organization as contact subject matter expert. Lead the organization in completion of annual records retention day.
• Expertise on Risk Management principles – carries out benefit/risk assessments for specific situations and provides operational Compliance advice.
• Work with Compliance and business process owners to:
• Coordinate all internal auditing and monitoring of document production requirements across the organization and the timely resolution of audit findings and related remediation plans
• Raise compliance awareness (e.g. communication at Nat'l Business meetings, leading Compliance Days, etc.)
• Implement corrective and preventative actions (CAPAs) as a result of compliance investigations/audit/monitoring observations.
• Act as business owner and primary point of contact for potential project owners for the NTA review and approval process towards all organizational stakeholders within the Regional Operating Unit((R)OPU) functions. Drive the implementation and the facilitation of the NTA review and approval process in a compliant and sustainable manner.
• Implement local Non Trial Activity (NTA) review and approval process and ensure process compliance according to global SOP and local legal requirements.
• Lead the classification, review and approval of NTA projects along with stakeholders (locally and globally)
• Consult with the global NTA manager as needed; lead the review and approval of high impact local NTA proposals with the corporate NTA Steering body
• Consult business NTA project owners, provide guidance and share expertise on best practice ways of working in close collaboration with global governance team
• Drive NTA process flow and consultation with Medicine, Pharmacovigilance (PV) and other functions as required
• Ensure and facilitate appropriate local NTA process trainings
• Track process performance according to defined metrics Key Performance Indicators (KPI).
• Monitor customer satisfaction to support process optimization.
• Actively participate in the global network of local NTA managers and Corrective Action Prevention Action (CAPA) master training.
• Support PV inspection and audit from NTA process and record keeping perspective.
• Ensure that NTA /PV/ Medical Review (MR) process is adhered
• Support General Data Protection Regulation (GDPR) procedure / contracts
• Be the Human Pharmaceuticals (HP) PV commercial lead / contact point
• Lead the Fair Market Value (FMV) assessment and approval process for all external experts engaged for various services (i.e., Speaking engagement, advisory board etc.) within Boehringer Human Pharma. Lead the establishment & optimization of standard operating procedures and process governance to process fair market value assessments of external stakeholders, aligned with the local and global FMV framework. Lead the implementation of the FMV Framework for Boehringer Human Pharma including owning accountability for the final approval for standard working level assessments for remuneration of external stakeholders.
• Accountable as Sponsorship Lead for HP organization. Lead the development and optimization of sponsorship management for the Human Pharma organization including leadership over the Sponsorship Review Committee and governance-setting for internal and external stakeholders. In addition, the role has oversight over the Sponsorship modules in Lectrona.
• Lead the ABAC Due Diligence monitoring process. Manage and execute ABAC (Anti-Bribery Anti-Corruption) screenings to uphold the organization’s integrity and prevent unethical practices. Continuously monitor and evaluate compliance with anti-bribery and anti-corruption policies and regulations. Work closely with legal, compliance, and other relevant departments to ensure a coordinated approach to ABAC compliance.
• Provide support during internal and external audits related to ABAC compliance

Benefits

• generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees)
• comprehensive and flexible benefits plan
• Defined Contribution Pension Plan with company matching of RRSPs
• Employee and Family Assistance Plan
• employee and leadership development programs
• programs to support overall health and wellness for employees

What This Job Offers

• Job Type: Full-time
• Career Level: Senior