Associate Director, Quality Assurance CDMO
Share
Job Location:
Devens, MA - USA
Monthly Salary:
$ 170000 - 190000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Company Description
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility we develop solutions and processes that support and accelerate innovation.
Job Description
Responsible for managing Quality Assurance group and directs day-to-day operationto ensure quality Assurance for Devens and North Andover position is responsible for implementing and managing cGMP compliant practices in the as well as deploying functional strategy within the department providing framework for effective teamwork setting objectives and ensuring development of Quality Assurance personnel.
Key Responsibilities / Accountabilities
- Evaluate and implement systems methods techniques and solutions to complex quality compliance issues.
- Host all regulatory agency and client audits.
- Interface with Clients for project planning and problem resolution with a strong customer service approach.
- Recommends and leads implementation of critical compliance systems and provide recommendations to operations management.
- Recommends the stop of any manufacture and/or distribution of a product if necessary.
- Manages the review approval and delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.
- Analyses trends associated with data proficiency testing equipment/supply/reagent defects and develop solutions as appropriate.
- Directs and advises the Quality Assurance group to achieve long and short-term goals and objectives.
- Develops improves and revises Standard Operating Procedures (SOPs) and Quality Policies as required/needed.
- Assures the qualification of suppliers and vendor management program.
- Ensures the review and approval of equipment qualification protocols and results.
- Participates in internal auditing programs to assure compliance with regulatory requirements and company standards.
- Partner collaboratively with Production Maintenance QC for all Quality decisions
- To carry out any other duties which are within the employees skills and abilities whenever reasonably instructed.
Qualifications
- BS or MS in Chemistry or related field required.
- Must have a minimum of 10 years of experience in Quality Assurance in an FDA regulated industry.
- Minimum of 5 years of supervisory experience required.
- Minimum of 10 years in laboratory environment preferably in API in GMP environment.
- Must have extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API)
- Knowledge and previous experience with GMP ICH Q7 and 21 CFR Part 11.
- Expertise in FDA regulations GMPs and Quality Systems relevant to pharmaceutical manufacturing.
- Demonstrate attention-to-detail problem solving and ability to make decisions quickly.
- Excellent analytical written and verbal communication skills required to demonstrateStrong technical writing and the ability to clearly express ideas.
- Proven ability to lead and coach and motivate employees clearly communicate job requirements and effectively manage performance of staff.
- Proven team player with well-developed interpersonal organizational mentoring and communication skills including written documentation.
- Knowledge of SAP LIMS Master Control and project management experience desired.
- Must be a change agent and have strong interest in learning and applying new techniques.
- Ability to change priorities in response to company demands while continuing to deliver exceptional work quality.
Salary Range
$170000.00 - $190000.00
Additional Information
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age race color national origin religion sex sexual orientation gender identity and/or expression physical or mental disability genetic information citizenship marital status veteran status or any other characteristic protected by federal state or local law.
All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
Our Commitment:
- Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
- Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary eligibility for performance-based bonuses and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role and are based on market data internal equity and role-specific factors. Final compensation may vary depending on experience skills education and business needs.
- Professional Development: Opportunities for continuous learning through LinkedIn Learning workshops conferences and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
- Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
How to Apply:
At Veranova we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visitto view all open roles and join ourTalent Communityto stay connected and learn about opportunities as they arise.
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients we encourage you to apply regardless of whether you meet every qualification listed.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age race color national origin religion sex sexual orientation gender identity and/or expression physical or mental disability genetic information citizenship marital status veteran status or any other characteristic protected by federal state or local law.
All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view ourprivacy notice.
#LI-Onsite
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Veranova is a global leader in the development and manufacturing of specialist and complex API ingredients for pharma and biotech customers.
