Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Document Quality, Manager.

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.

The annual base salary for this position ranges from $90,800.00 to $151,300.00.

How You Will Achieve

• Perform quality reviews to ensure accuracy, consistency and completeness of documents deemed for regulatory submission in accordance with agreed upon timelines. Quality reviews will potentially include Lightspeed programs/products and accelerated submissions.
• Collaborates with document authors and other team members to address and resolve quality observations.
• Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes, process improvement initiatives, and strategies supporting accelerated advancement of products.
• Participates in the investment and strategy decisions related to technology enhancements.
• Supports regulatory commitments and expectations, including commitments for programs within accelerated timelines.
• Maintains knowledge of global regulatory requirements relative to pharmacovigilance and regulatory submission requirements.
• Provides support for regulatory inspections and internal audits which may include requirements related to Lightspeed projects and/or high profile products.
• Provides mentoring and training for colleagues as necessary, working with Team Leads to provide support across all sites.
• Actively participates in the investment and strategy decisions related to technology enhancements.
• May serve as quality Subject Matter Expert (SME) on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate.
• Lead quality reviews to ensure accuracy, consistency and completeness of documents deemed for regulatory submission in accordance with agreed upon timelines. Quality reviews will potentially include Lightspeed1 programs/products and accelerated submissions.
• Leads project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality processes, process improvement initiatives, and strategies supporting accelerated advancement of products.
• Actively participates/leads in the investment and strategy decisions related to technology enhancements.
• Leads support activities for regulatory inspection and internal audits which may include requirements related to Lightspeed projects and/or high profile products.
• Compiles and analyzes quality metrics on a routine basis, and periodically reports trends relating to document quality review.
• Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers, as necessary.
• Serves as quality SME on training, knowledge sharing, technology or specific work processes, providing advice and guidance as appropriate.
• Participates in the development of people, including recruitment and retention, working with the SQ DQC Team Leads to provide support to other colleagues across all sites.
• Participates in the development of work guides, training materials.
• Assists in developing recommendations for processes to ensure alignment with quality goals and other groups performing similar functions.

Qualifications

Must-Have

• BS degree (or equivalent) with 5 years of experience or Master's degree with 3 years of experience.
• Experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
• Experience in quality control and/or quality assurance within the pharmaceutical industry preferred.
• Knowledge of global safety regulations and guidelines, or equivalent.
• Demonstrated strength in analytical skills and attention to detail.
• Demonstrated strength in oral/written communication and interpersonal skills.
• Demonstrated organizational/project management skills.
• Ability to make decisions independently and resolve issues appropriately.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
• Broad knowledge of global safety regulations and guidelines, or equivalent.
• Innovative and strategic thinking ability.
• Extensive clinical development and/or post-marketing and business experience to have a thorough understanding of the processes associated with clinical safety and regulatory operations.

Nice-to-Have

• A health care, scientific or technical degree is preferred.

Technical Skill Requirements

• Strategic Thinking - Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions, especially for programs/products with Lightspeed1 designation and accelerated submissions.
• Clinical, Regulatory and Safety Expertise - General understanding of medical terminology and demonstrated knowledge of clinical research processes, safety or regulatory requirements.
• Multitasking - Demonstrated ability to effectively work on simultaneous projects/deliverables.
• Analytical and Statistical Skills – Demonstrated analytical and statistical skills.
• Systems Technologies – Thorough understanding of system technologies that support the business.
• Strategic Thinking – Demonstrated expertise and ability to understand and consider competitive positioning when solving problems and making decisions, especially for programs/products with Lightspeed1 designation and accelerated submissions.
• Clinical, Regulatory and Safety Expertise - General understanding of medical terminology and extensive knowledge of clinical research processes, safety or regulatory requirements.
• Technical Expertise - Applies broad-based technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line. Strong risk management expertise.
• Project and Process Management and Meeting Established Deadlines – Demonstrated ability to lead multiple complex projects and cross-functional processes independently, and to meet established deadlines. Flexible approach to working schedule may be required.
• Presentation/Influencing/Organizational Skills – Excellent platform skills evident.
• Multitasking – Demonstrated ability to effectively and independently work on simultaneous complex projects/deliverables.
• Analytical and Statistical Skills - Extensive analytical and statistical skills.
• Systems Technologies - Comprehensive understanding and expertise with system technologies that support the business.
• Proficient with software commonly used to present and analyze data (Word, PowerPoint, and Excel) required.
• Excellent analytical skills with experience in generating business metrics highly desirable.
• Previous experience in KPIs dashboard and data visualization highly desirable.
• Demonstrated ability to collaborate effectively with team members and interact at all levels of an organization.
• Demonstrated ability to analyze, evaluate, understand processes quickly, and identify gaps, issues and opportunities for improvement.
• Strong orientation to detail and ability to function independently as appropriate.
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multitasking skills.
• Ability to engage colleagues globally and will do so in a manner that recognizes the organizational and cultural differences may exist between their partners around the world
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Can manage multiple deliverables/projects simultaneously, prioritizing well and recognizing key issues and recommends course of action to management.

Job Type: Full-time

Pay: $90,800.00 - $151,300.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person