Compliance Solutions Manager
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jun 23 2021 Are you interested in a compliance leadership role that enhances your project management capability and allows you to shape ethics and compliance across the Research and Development business? If so, this Compliance Manager could be an exciting opportunity to explore. As a Compliance Manager, you will be responsible for managing all associated risks to GSK. You will also monitor and develop the organization's internal processes, programs, systems and policies to ensure they follow government, corporate and company regulations and upholds a high standard of governance and ethics throughout the organization. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Exhibit key behaviors and communication styles must be right-sized for stakeholders and project needs so that the individual is visible, present and take controls of discussions, surfaces the issues and recommends next steps. Serves as key management contact and will be empowered to make recommendations and decisions where required. Provide project management support as needed, elsewhere within the context of goals and objectives Champion Biopharm Product Development & Supply wide implementation of Internal Control Framework and Risk Management Remain current of regulatory trends and requirements, adapting practices and understanding the operational aspects and impacts of proposed solutions are key remits when engaging Biopharm Product Development & Supply and their external partners Lead, support and influence EHS implementation and continuous improvements throughout Biopharm Product Development & Supply areas Develop strategies for Biopharm Product Development & Supply to be ‘future ready' with proactive identification, escalation and engagement of staff for building a best-in-class Quality Culture at department meetings. When asked, support special projects and lead compliance activities for identifying, planning and execution quality and/or compliance solutions at local or enterprise levels for GSK assets. Understanding stakeholders, building teams, sharing knowledge and know-how and fostering the best decision making possible and at the correct time needed Integrating culture, policy and procedure, people and processes, products and patients so that quality, risk and compliance are present in efforts to deliver medicine to patients; and, do so in such a manner as to streamline work without overburdening existing resources Internal and external activities may include but are not limited to: Working with R&D/ PSC counterparts to fulfill OnePharma goals and objectives Biopharm Product Development & Supply Lead for implementation of the EHS compliance program including performed management monitoring for the platform, coordination of gap assessments and implementation of EHS objectives Act as a SME and lead during external regulatory inspections, internal reviews and audits (e.g. Joint Risk Review, Independent Business Monitoring, Management Monitoring) Provide vision and leadership to Biopharm Product Development & Supply compliance forums/ meetings Lead the Management Monitoring Program for Biopharm Product Development & Supply including driving continuous improvements Identifying, assigning and collaboratively engaging GSK functions, including Quality Assurance. Representing department at internal forums (risk management, quality council, change management, project teams) and external entities where appropriate (due diligence for suppliers, management monitoring) for activities and how to best align fulfillment with GSK Values Develop, manage, implement and communicate right sized compliance programs and continuous improvement initiatives as required Provide mentoring and focus-training as required to support platform initiatives. Liaise between Biopharm Product Development & Supply departments for development, understanding and implementing quality systems and processes aligned with QMS and GSK Policy. Remain informed of current QMS, FDA, EU, PMDA, MHRA and other relevant industry standards and ensure their assessment of compliance risks and action plans; and, provide strategy and implementation recommendations for demonstrating compliance with applicable regulations Understand stakeholders, build teams, knowledge share and foster the best decision making possible Escalating for awareness, consideration and action concerns/ risks which may impact or disrupt delivery of medicines in the pipeline or safety of the people at GSK. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS Degree minimum 10 years of relevant industry experience Experience with compliance, EHS programs, quality systems and/or audit coordination. Experience leading a cross business/cross functional team. Preferred Qualifications: If you have the following characteristics, it would be a plus: Proactive stakeholder management and relationship building with internal or external parties which includes managing multiple or particularly critical stakeholders and influencing the broader agenda outside of your business or organization. Experience managing a large or very complex organization initiative, driving effective ways of working, interaction and connectivity and ensuring delivery through systems, processes, and people. Ability to independently applies knowledge in area of specialization to assignments that involve multiple decision points. Experience applying extensive technical knowledge to form new ideas, concepts and methods; may act as an internal consultant in area of expertise. Strong project management skills. Deep knowledge of GxP requirements, SOP's and policies; and, regulatory requirements. Capable of managing/executing several projects/activities at different stages of development. Anticipates and recognizes potential problems and initiates actions to solve or prevent problems. Prioritizes activities to meet project or department objectives. Supervisory, matrix lead responsibility or experience leading, motivating, and providing performance feedback for team members. Consistently exhibits GSK Leadership Capabilities and serves as a role model for others. Independently prepares and effectively communicates oral and written summaries/reports of results, conclusions and subsequent actions for next steps. Presents effectively to internal R&D forums and may present results at external meetings. Develops networks with both internal and external contacts relative to projects and/or processes. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK GSKBiopharm_Development If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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