Associate Director/Sr. Manager, GMP StrategyLocation Apply
Senior Manager/Associate Director, GMP Strategy
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.
As the GMP Compliance Strategy Lead, the AD/Senior Manager is responsible for developing, executing, and managing the Good Manufacturing Practices (GMP) Compliance program at BioMarin. This role advises internal and external key stakeholders on GMP 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.
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
- Participate in chemistry, manufacturing and controls (CMC) team meetings and other relevant forums to provide compliance expertise to influence global compliance strategies and alignment
- Provide compliance expertise and strategic leadership for clinical and commercial programs by partnering with Technical Operations and other stakeholders
- Partner with CMC team(s) and the Quality organization to identify compliance deliverables for the program(s)
- Facilitate inspection readiness across the program portfolio of manufacturers and labs as they graduate towards commercial approval and thereafter
- 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
- Interface with stakeholders in an advisory fashion to influence compliance in operations
- Establish and report effective, risk based KPIs to help identify, communicate, and manage key compliance trends and issues by program
- Maintain expert level knowledge of compliance requirements and industry trends, including relevant modalities such as gene therapy, small molecules, and enzyme replacement therapies (ERTs)
- 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 on multiple GMP/TOPS forums and provide updates
- Coordinate communications and report on compliance programs, such as audit and contractor nominations, associated with each program
- 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
The Senior Manager will be a subject matter expert and may indirectly lead or manage a team. This position will contribute to and make an impact on the department and the cross-functional process.
CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS
- 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
- Acts as subject matter expert in both the understanding and interpretation of global regulations and guidance
- BA/BS degree with a focus on life sciences or a related scientific or technical discipline
- 8+ years clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS
- One year of people management experience preferred
Computer work utilizing common business software programs and hardware solutions.
This position will interact with a range of personnel across the organization, including but not limited to other Compliance personnel and staff in Technical Operations, Regulatory, Clinical Operations, Medical Affairs, and others.
*May travel up to 25% of the time (and as dictated by COVID protocols).
*No supervisory responsibilities.
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.