Associate Director Quality Assurance
Catalent Inc, Phila, PA, United States
Associate Director, Quality Assurance
Position Summary:
This is a full-time salaried position
Based onsite out of Philadelphia, PA office
T?he
Associate Director, Quality Assurance
is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, improving activities related to process and support to business demands.
Our Philadelphia facility is our North American Center of Excellence for clinical supply packaging.
The Role:
Quality liaison for clients and internal customers; is expected to become the owner or escalation point for client requests/issues
Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus
Participate in Regulatory Inspections and Customer Audits, etc
Participate in site and customer meetings/communications and be directly involved in critical projects/issues
Establishes goals and monitors performance through monthly, quarterly, and annual summaries and metrics
Present summary data to site management on a regularly scheduled basis
Provide QA Technical recommendations based on trend analysis to eliminate future problems
Participates in project meetings to provide input with respect to compliance to cGMP requirements
Other duties as assigned
The Candidate:
Bachelor's degree in scientific discipline, chemistry, biochemistry, biology, microbiology, or chemical engineering, required
Minimum of 10 years' relevant experience in the pharmaceutical industry
Minimum four years of leadership/management experience with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives
Working knowledge of cGMPs regulations, required; prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
Experience working with customers - Contract manufacturing experience, preferred
Prior experience working with quality control, or GMP manufacturing/packaging, preferred
Prior experience working directly with regulatory agencies and handling inspections, preferred
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
Why You Should Join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
WellHub - program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
Position Summary:
This is a full-time salaried position
Based onsite out of Philadelphia, PA office
T?he
Associate Director, Quality Assurance
is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, improving activities related to process and support to business demands.
Our Philadelphia facility is our North American Center of Excellence for clinical supply packaging.
The Role:
Quality liaison for clients and internal customers; is expected to become the owner or escalation point for client requests/issues
Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus
Participate in Regulatory Inspections and Customer Audits, etc
Participate in site and customer meetings/communications and be directly involved in critical projects/issues
Establishes goals and monitors performance through monthly, quarterly, and annual summaries and metrics
Present summary data to site management on a regularly scheduled basis
Provide QA Technical recommendations based on trend analysis to eliminate future problems
Participates in project meetings to provide input with respect to compliance to cGMP requirements
Other duties as assigned
The Candidate:
Bachelor's degree in scientific discipline, chemistry, biochemistry, biology, microbiology, or chemical engineering, required
Minimum of 10 years' relevant experience in the pharmaceutical industry
Minimum four years of leadership/management experience with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives
Working knowledge of cGMPs regulations, required; prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
Experience working with customers - Contract manufacturing experience, preferred
Prior experience working with quality control, or GMP manufacturing/packaging, preferred
Prior experience working directly with regulatory agencies and handling inspections, preferred
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
Why You Should Join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
WellHub - program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .