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Deviation Program Manager
Souderton, PA
Job Description
Almac Group is currently seeking a Deviation Program Manager for our Souderton, PA. Durham, NC or Northern Ireland locations. location. The Deviation Program Manager is responsible for oversight of the investigation and CAPA management process globally and ensure alignment with the company strategy. In doing so the post-holder will work closely with Lead Investigators and their Line Managers, Quality approvers and departmental Heads, to ensure sufficient, competent resource is available to deliver on the strategy, drive continuous improvement that is evident within the Pharmaceutical Quality System.
Responsibilities include but are not limited to:
Collaborate closely with Senior Management to further develop and implement strategy for the investigation, complaints and CAPA management process. Provide regular status updates.
- Lead the adoption and development of processes within Veeva Vault relevant to deviation management.
- Support Quality Assurance Managers globally with educational material and feedback to support the continued development of standardized consistent Quality review and approval processes across each Clinical Services' site.
- Collect and analyze data globally and maintain oversight to ensure consistency in reporting, classification, allocation of causes and defects within the Veeva Vault system.
Design and implement a program to facilitate the successful on-boarding of new Lead Investigators with clear milestones to meet within an agreed timeline. Collaborate closely with departmental On-the-Job Trainers.
- Be involved in the recruitment and selection of new Lead Investigators, ensuring adequate trained resource is available to conduct investigations and ensure the timely review and approval of all investigations.
- Generate high-quality educational material to support the development of Lead Investigators.
- Coach Lead Investigators in the application of technical knowledge and soft skills and evaluate their understanding.
Implement a process to monitor and assess the output of new and experienced Lead Investigators ensuring a consistent, high-quality approach to investigations. Provide Lead Investigators and their Managers with feedback on their performance.
- Provide feedback to Line Managers with input into the learning needs analysis of Lead Investigators to identify knowledge and skills gaps.
- Work closely with the Line Managers to create opportunities for their continuous development to broaden their areas of specialism, provide them with new skills and increased competence.
- Establish tools to monitor workload and capacity globally and support Quality Assurance managers to ensure incidents are evenly distributed throughout the pool of Lead Investigators, investigated in a timely manner and prioritized appropriately.
Qualifications:
Required Experience / Education:
- Bachelors Degree (or equivalent)
- 4+ years Pharmaceutical Experience (with Associates Degree)
- 2+ years Pharmaceutical Experience (with Bachelors Degree)
- Knowledge of Current Good Manufacturing Practices (cGMP)
- Performing, approving or managing the completion of deviations and complaints
- Completing GMP documentation
- Working with Quality Systems
Preferred Experience / Education:
- Bachelors Degree in scientific discipline
- Previous experience working under an established Quality System or within a Pharmaceutical / GXP environment
- Knowledge of Packaging/Labeling/Storing/Shipping Clinical Supplies
- Familiar with Clinical Trial Process
What can Almac Group offer you?
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. 'Partnering to Advance Human Health' is more than just a tagline - it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV's not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at to request assistance.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
4+ years
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