Sr. Manager, GCP Strategy

Location
Working from Home
Posted
Jun 15, 2021
Ref
oHptffwy
Required Education
Bachelors Degree
Position Type
Full time
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care and providing personalized support and services globally. 

The BioMarin GxP Compliance function is tasked with providing independent assurance services designed to enhance scientific innovation with effective risk management. The GxP Compliance team partners with the business to strengthen the commitment to compliance by advising cross-functional teams through the Strategy subfunction, identifying and mitigating risk through the Audit subfunction, and leading distribution and proactive compliance through the Operations subfunction.

Within GxP Compliance, the Strategy subfunction serves to provide advising on elements of GxP Compliance to cross-functional Product, Program, and/or Study Teams, monitoring and providing compliance expertise through the program lifecycle, and supporting regulatory submissions. The GxP Strategy subfunction also provides compliance guidance on GxP topics and provides insight to the audit team to inform audit approaches.

Strategy Lead:

As a GCP Compliance Strategy Lead, the Senior Manager is responsible for developing, executing and managing the Good Clinical Practices (GCP) Compliance program at BioMarin. This role advises internal and external key stakeholders on GCP matters and assesses compliance with international regulations/guidelines, corporate policies, and standard operating procedures. This individual is a key point of contact supporting regulatory inspections for assigned products and identifies, and works in partnership with stakeholders to resolve, regulatory compliance risks and related issues.  

RESPONSIBILITIES

Compliance strategy and execution

  • Liaise with all program/product leads from GxP Strategy organizations to maintain a comprehensive view of the program’s compliance status
  • Act as a subject matter expert by providing GCP compliance advice to the assigned clinical program(s), including training and updates for applicable regulations
  • Work with internal and client group leaders to proactively identify, communicate/escalate, and mitigate material compliance risk
  • Influence decision makers and utilize sound problem-solving skills to recommend options for implementation of compliant and effective solutions
  • Provide assistance or guidance to the responsible parties in developing and completing corrective and preventive action plans
  • Provide quality reviews of protocols, amendments, and other study-specific documents as requested for consistency and acceptable standards and practices to ensure compliance with internal standards, regulations, and ICH GCP guidelines
  • Assist with tracking GCP Compliance audit trends and group metrics
  • Act as the GCP compliance lead on regulatory inspection readiness teams. Participate as a core member on the regulatory inspection team, provide leadership during regulatory inspections, and oversee the development and tracking of regulatory commitment
  • Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to BioMarin policies and practices to maintain proactive compliance
  • Maintain expert level knowledge of compliance requirements and industry trends, including relevant modalities such as gene therapy, small molecule applications, and enzyme replacement therapies (ERTs)
  • Participate in the development and/or enhancement of GCP Strategy and GxP Compliance business processes, procedures, and best practices

Audit preparation and conduct

  • Lead or support audit activities for investigator sites
  • Assure the integrity and quality of clinical data by independently managing, leading, participating, and following up on audits for assigned program(s), including routine and directed, internal and external, domestic and international GCP audits
  • Prepare and lead audits across multiple internal sites and third parties, both domestic and international, including:
  • Lead vendor audit scheduling and prioritization
  • Lead pre-audit meeting with internal stakeholders to determine current audit status and review pre-audit documentation
  • Define the audit agenda, focusing on high-risk areas
  • Execute the audit, including traveling to the site and associated administrative tasks
  • Prepare audit report in Trackwise, including internal and external reports
  • Escalate critical non-compliances/potential risks to Group Head
  • Debrief internal and external stakeholders
  • Manage audit responses, including assessing whether response meets regulatory authority, local authority, and BioMarin requirements
  • Engage with GxP Strategy partners to obtain regulatory intelligence business risk area guidance, as needed, and keep them informed throughout the audit process
  • Confirm corrective actions and close-out
  • Track and manage corrective and preventative actions (CAPAs) to completion
  • Serve as subject matter expert for audits in the GCP area, providing researched and fact-supported information and opinions on complex issues that lack precedence
  • Communicate regularly with partners to build relationships and identify audit needs
  • Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation
  • Participate in due diligence activities
  • Distribute study, vendor, and internal audit and inspection reports. Assure departmental audit reports and any other supporting documentation are appropriately processed in the TrackWise database and Archives
  • Support audits or training of auditors for clinical vendors, study reports, and internal systems
  • Assure the integrity and quality of clinical data by independently managing, leading, participating, and following up on audits for assigned program(s), including routine and directed, internal and external, domestic and international GCP audits

 

Cross-functional engagement

  • Act as a subject matter expert by providing GxP Compliance advice and counsel to internal stakeholders, including training and updates for applicable regulations and guidelines
  • Inform stakeholders regarding compliance trends and changes
  • Participate in the development and/or enhancement of corporate GxP Compliance processes, procedures, and best practices
  • Actively represent the Compliance organization in relevant forums and provide updates
  • Provide input to the Audit team on risk-based audit planning/scheduling and appropriateness of corrective actions for audits of internal and external entities
  • Represent Compliance during issue management and escalation scenarios. Communicate critical information regarding significant quality or patient safety risk to senior/executive management and key stakeholders

SCOPE

The Senior Manager will be a subject matter expert. This position will contribute to and make an impact on the department and the cross-functional process.

SUPERVISOR RESPONSIBILITY

This role does not have direct reports.

CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS

Core Competencies

  • Creates a team/working environment that encourages open dialogue and questioning of status quo, assumptions and the exploration of innovative and novel solutions
  • Obtains appropriate key stakeholder and/or decision maker buy-in to any recommended solution even in contentious scenarios
  • Demonstrates an understanding of organizational structure, key decision-making processes and governance and communication channels
  • Demonstrates the ability to garner support from peers and positively influence outcomes, decisions, or group direction
  • Inspires, motivates and empowers employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence
  • Demonstrates an ability and eagerness to actively contribute to team efforts in a positive and constructive manner, including by taking on a leadership role within own area of work when needed
  • Adapts communication style, message and delivery method and medium to audience; knows when to ask for guidance on complex or difficult messages
  • Able to facilitate small and large meetings efficiently and effectively across functions, promoting collaboration, meeting stakeholder needs, and accomplishing meeting objectives
  • Develops and communicates short and long-term priorities through an assessment of future trends and current strategy

Technical Competencies

  • Acts as subject matter expert in both the understanding and interpretation of global regulations and guidance

EDUCATION

  • BA/BS degree with a focus on life sciences or a related scientific or technical discipline

EXPERIENCE

  • 8+ years clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS
  • One year of people management experience preferred

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions.

CONTACTS

This position will interact with a range of personnel across the organization, including but not limited to other Compliance personnel and staff in Regulatory, Clinical Operations, Medical Affairs, and others.

May travel up to 25%


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.