Senior Manager, Synthetics Product Quality Integrator (PQI)
About The Position
The PQI senior manager has end-to-end accountability for the quality strategy and quality aspects of a product portfolio from development through end-of-lifecycle. Develops and leads the quality strategies to support new products and/or platforms. Leads a global quality and compliance team responsible for clinical/commercial product quality. Discusses, reviews and approves product documentation such as specifications, investigations, regulatory filings, maintaining the highest quality and compliance standards. Works with high performing cross-functional teams to identify risks and mitigations, resolve issues, enabling on-time regulatory submissions and launches. Connects with stakeholders, serving as the Product Quality single point of contact, providing regular updates to peers and leaders.
Requirements
- Minimum 7 years of experience in quality, compliance or regulatory affairs in a regulated industry.
- Minimum of Master / Bachelor´s degree in a scientific discipline, and it is essential that the individual has excellent scientific & technical capabilities based on a combination of qualification and experience.
- Experience in one or more GMP Quality related disciplines is essential including, but not limited to, manufacturing and packaging operations, analytical testing and basic knowledge of new product introduction.
- Experience in a successful leadership role in building, inspiring and managing a global team and influencing across a matrix organization structure.
- Excellent communication and organization skills required.
- Strong presentation, written and oral communication skills as well as the ability to meet due dates.
- Attention to detail and analytical / problem-solving skills.
- Business oriented, independent, and driven.
- Proficient in English.
Nice To Haves
- Hands-on experience with Artificial Intelligence applied to scientific problem solving, in a regulated environment, is a plus.
- Experience with scientific models for real-time-release, continuous manufacturing, new modalities (e.g. antibody drug conjugates), is a plus.
Responsibilities
- Is guided by Our CREDO.
- Ensures high quality products for patients.
- Represents Global Quality in CMC and Value Chain Teams.
- Establishes and develops strong working relationships with business partners globally.
- Ensures Quality milestones and Quality stage gate deliverables are met on time.
- Reviewers / approves health authority submissions (i.e. IND, NDA, MAA) and filing response documents.
- Provides Quality inputs to commercial sourcing decisions.
- Leads a global quality and compliance team responsible for clinical/commercial product quality.
- Working proactively to understand risks, develop mitigation strategies and communicating with management.
- Supports the preparation of mock PAI and PAI audits for the products assigned and participates in audits as needed.
- Ensures that Global Quality processes are followed, maintained and communicated across sites (e.g. criticality analysis, escalation, complaints).
- Represents Quality and/or leads project teams as assigned.
- Remains current in knowledge, skills, industry trends, draft guidelines and new regulations.
- Escalates issues when appropriate.
- Works with cross functional teams to coordinate and hold Escalation meetings, participates and/or leads Issue Management teams.
- Supports field actions / recalls as needed.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
