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Actalent Pharma QA Compliance Manager - Regulatory! in Durham, North Carolina

Description: A well known biopharmaceutical company is looking for an experienced Quality Systems/Compliance specialist with a passion for regulatory affairs to join their team.

Role and Responsibilities:

The Manager, QA Compliance will report into the Global Quality Systems & Compliance department. This role will be primarily responsible for the development and implementation of a Regulatory Intelligence (RI) program for PDM to maintain GMP state of control. This role involves analysis and communication of key insights and implications of the changing regulatory landscape to senior leadership and business partners. The role is highly visible and requires strong leadership and collaboration with cross-functional stakeholders.

• Define RI priorities and roadmap to proactively address regulatory challenges and business needs in collaboration with cross-functional partners

• Support cross-site, cross-functional socialization effort for the RI program to raise awareness and promote branding

• Implement and improve the process for sustainably collecting, evaluating, and adopting regulations and guidance based on data, science and risk management principles

• Design and author GMP RI newsletters to arm PDM staff with timely and actionable knowledge by aggregating and distilling information across multiple GMP subscription services, industry consortiums, and open meetings sponsored by health authorities

• Effectively support communication of regulatory trends, insights and implications to leadership with presentations and written reports

• Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training

• Develop and maintain online platforms (e.g. Tableau, SharePoint) to provide real-time intelligence related to products, internal and external manufacturing and testing sites

• Leverage data analytics to improve existing RI tools and capabilities

• Facilitate risk assessment of inspection outcomes at contract manufacturers and testing labs

• Coach and mentor junior staff supporting RI program deliverables

• Other responsibilities as required

Essential Duties and Job Functions:

• Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs

• Strong oral and written communication

• Demonstrates thorough knowledge of compliance requirements and understanding of current global and regional trends in compliance

• Ability to analyze, interpret and distill large amounts of information into key messages

• Ability to operate with incomplete information

• Accountable to own actions and keep commitments

• Strives to continuously build knowledge and skills; and shares expertise with others

Additional Skills & Qualifications:

Knowledge, Experience and Skills:

• Experience with researching, developing, and delivering RI reports and tools

• Experience in use of online data sources and scientific/market databases (e.g., fda.gov, PDA, ISPE, Pharma Intelligence)

• Working knowledge and hands-on experience with risk management tools (e.g., FMEA, risk ranking and filtering)

• Excellent interpersonal skills including ability to effectively speak with courage and candor across organizational levels and functions

• Charismatic leader with strong relationship building skills, and ability to influence and negotiate with cross-functional stakeholders

• Able to maintain a balance between being strategic/big-picture thinker and taking deeper tactical dives as needed

• Experience in developing and generating quality system metrics/trending

• Excellent task and time management skills (e.g., project planning, prioritization)

• Demonstrated ability to perform in a fast-paced environment

Basic Qualifications:

• 6+ years of relevant experience in the pharmaceutical industry

• Must be able to support West Coast (PST/PDT) hours

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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